Clinical trial NCT05071807
Conditions: Cardiovascular Diseases
Sponsor: Penn State University
Start date: 2022-08-15; Completion date: 2024-03-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, 2-arm, parallel trial will be conducted to examine the effect of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

Detailed description:
A randomized, 2-arm, parallel trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, compared to a diet typically consumed by participants intake (devoid of nuts) on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control. Participants will be randomized to pecans or control for 12-weeks. Outcome assessments will be measured at baseline and 12-weeks.

Arms: arm 1: Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack arm 2: Participants will consume their usual diet devoid of nuts
Interventions: intervention 1: Pecans intervention 2: Usual Care
Intervention descriptions: intervention 1: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks. intervention 2: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.

Protocol documents:
Prot_004.pdf: 
Page 1 of 45 (IRB USE ONLY: V. 03/01/2021)  
                                                      
 
 
 
 
 
 
 
 
 
 
 
 
 
Cardiometabolic Effects of Pecans as a Snack 
NCT05071807 
September 19,2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                 
 
 
HRP-591 - Protocol for  


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Human Subject Research 
 
Protocol Title: 
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu).  
Cardiometabolic effects of including pecans as a snack to improve diet quality: a randomized controlled study 
 
Principal Investigator: 
Name: Kristina Petersen 
Department: Nutritional Sciences 
Telephone: 814-865-7206 
E-mail Address: kup63@psu.edu 
 
Version Date: 
Provide a version date for this document. This date must be updated each time this document is submitted to the IRB 
office with revisions.  DO NOT revise the version date in the footer of this document.  
  September 19,2023 
Clinicaltrials.gov Registration #: 
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual”, under 
“ClinicalTrials.gov” for more information.  
NCT05071807 
Important Instructions for Using This Protocol Template: 
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the 
IRB to determine whether a study meets all applicable criteria for approval. 
 
1. 
GENERAL INSTRUCTIONS:   
• 
Prior to completing this protocol, ensure that you are using the most recent version by verifying the protocol 
template version date in the footer of this document with the current version provided in the CATS IRB 
Library. 
• 
Do not change the protocol template version date located in the footer of this document. 
• 
Some of the items may not be applicable to all types of research.  If an item is not applicable, please indicate 
as such or skip question(s) if indicated in any of the instructional text.  
• 
GRAY INSTRUCTIONAL BOXES: Type your protocol responses below the gray instructional boxes of guidance 
language.  If the section or item is not applicable, indicate not applicable. 
o Do NOT delete the instructional boxes from the final version of the protocol. 
• 
Add the completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic 
Information” page.   
 
2. 
CATS IRB LIBRARY:  
• 
Documents referenced in this protocol template (e.g. SOP’s, Worksheets, Checklists, and Templates) can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
3. 
PROTOCOL REVISIONS:  
• 
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in 
the guides available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes.  
• 
Update the Version Date on page 1 each time this document is submitted to the IRB office with revisions. 
 
If you need help… 
 
All locations:  
Human Research Protection Program 
Office for Research Protections 


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The 330 Building, Suite 205 
University Park, PA 16802-7014 
Phone: 814-865-1775 
Fax: 814-863-8699 
Email: irb-orp@psu.edu 
https://www.research.psu.edu/irb 
 
 


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Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Number of Subjects and Statistical Plan 
9.0 
Data and Safety Monitoring Plan 
10.0 
Risks 
11.0 
Potential Benefits to Subjects and Others 
12.0 
Sharing Results with Subjects 
13.0 
Subject Payment and/or Travel Reimbursements 
14.0 
Economic Burden to Subjects 
15.0 
Resources Available 
16.0 
Other Approvals 
17.0 
Multi-Site Study 
18.0 
Adverse Event Reporting 
19.0 
Study Monitoring, Auditing and Inspecting 
20.0 
Future Undetermined Research: Data and Specimen Banking 
21.0 
References 
22.0 
Confidentiality, Privacy and Data Management 
 
 
 


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1.0 
Objectives 
 
1.1 
Study Objectives 
Describe the purpose, specific aims or objectives.  State the hypotheses to be tested. 
 
The purpose of the proposed study is to examine how replacement of habitually consumed snack foods 
in the U.S. with 2 oz./day of pecans affects markers of peripheral vascular health, lipids and lipoproteins, 
blood pressure, and glycemic control compared to usual U.S. intake. 
 
The aims of the study are as follows: 
1) To evaluate whether consuming 2 oz/day of pecans as a snack improves flow mediated dilation 
compared with habitual intake in individuals at elevated risk for cardiovascular disease; 
2 To assess changes in pulse wave velocity, lipids and lipoproteins (concentration, particle size and 
number), blood pressure (central and peripheral) and glycemic control in each group.  
 
Hypothesis:  
It is hypothesized that replacement of typical snack foods with 2 oz./day of pecans will improve 
peripheral vascular assessments, lipid and lipoprotein profile and glycemic control compared to habitual 
average American intake. 
 
1.2 
Primary Study Endpoints 
State the primary endpoints to be measured in the study.   
 
Clinical trials typically have a primary objective or endpoint. Additional objectives and endpoints are 
secondary.  The endpoints (or outcomes), determined for each study subject, are the quantitative 
measurements required by the objectives.  Measuring the selected endpoints is the goal of a trial 
(examples: response rate and survival). 
 
Flow Mediated Dilation (FMD) 
 
1.3 
Secondary Study Endpoints 
State the secondary endpoints to be measured in the study. 
 
Lipids and Lipoproteins (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) 
Lipoprotein particle size and number (LDL-cholesterol, HDL-cholesterol, VLDL and chylomicrons) 
Pulse Wave Velocity (PWV) 
Peripheral and Central Blood Pressure 
Insulin, HbA1c and Fasting Glucose 
Dietary intake of macronutrients, nutrients, and food groups 
Diet Quality  
Gut Microbiota composition 
 
2.0 
Background  
 
2.1 
Scientific Background and Gaps 
Describe the scientific background and gaps in current knowledge.  
 
For clinical research studies being conducted at Penn State Health/Penn State College of Medicine, and 
for other non-PSH locations as applicable, describe the treatment/procedure that is considered standard 


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of care (i.e., indicate how patients would be treated in non-investigational setting); and if applicable, 
indicate if the study procedure is available to patient without taking part in the study. 
 
Current Dietary Guidelines for general health and prevention of chronic disease recommend a healthy 
dietary pattern U.S. Department of Health and Human Services (2016). In the U.S., habitual dietary 
patterns do not align with recommended health dietary patterns. Further, diet quality is suboptimal and 
thus strategies are needed to improve overall diet quality.  The proposed trial aims to examine the 
cardiometabolic effects of pecans, when replacing a habitual snack. This trial will test the hypothesis that 
dietary incorporation of pecans to replace typical U.S. snack foods will improve diet quality and confer 
cardiometabolic benefits.  
 
Pecans have the highest polyphenol content of any nut containing 1816 mg/100g (Ros, 2015). A significant 
proportion of the polyphenol content is flavanols (494 mg/100g), which are present in higher quantities 
than dark chocolate (246 mg/100g), blueberries (332 mg/100g) and red wine (313 mg/100g) (Gu et al., 
2004). A meta-analysis of 11 studies showed that flow mediated dilation (FMD), a measure of endothelial 
function, increased by 1.34% after 2-18 weeks of consuming chocolate/cocoa/flavanols (Hooper et al., 
2012). This change in FMD is clinically significant; for every 1% increase in FMD, the risk of CVD is reduced 
by 12% (Matsuzawa, Kwon, Lennon, Lerman, & Lerman, 2015). Furthermore, Balzer et al. showed flavanol 
rich cocoa containing 371 mg or 963 mg of flavanols improved FMD for 2 to 3 hours after consumption; 
consumption of 963 mg of cocoa flavonols for 30 days increased FMD by ~30% (Balzer et al., 2008). In the 
proposed study, the subjects will consume approximately 212 mg of flavanols (781 mg total polyphenols) 
from pecans as part of the healthy dietary pattern. Therefore, based on previous studies of phenolic rich 
foods, we hypothesize that the polyphenols in pecans will act on the vasculature to improve endothelial 
function. 
Nuts, including walnuts, almonds, hazelnuts, pistachios and peanuts, improve endothelial function (Casas-
Agustench, Lopez-Uriarte, Ros, Bullo, & Salas-Salvado, 2011; Neale, Tapsell, Guan, & Batterham, 2017), 
lipids and lipoproteins (Del Gobbo, Falk, Feldman, Lewis, & Mozaffarian, 2015), and glycemic control 
(Tindall, Johnston, Kris-Etherton, & Petersen, 2019; Viguiliouk et al., 2014). Previous studies have not 
investigated the effect of pecans on endothelial function. Three studies have shown that pecans tended 
to reduce total and LDL-cholesterol when consumed for 4 or 8 weeks, compared to a control diet without 
nuts (McKay, Eliasziw, Chen, & Blumberg, 2018; Morgan & Clayshulte, 2000; Rajaram, Burke, Connell, 
Myint, & Sabaté, 2001), which would be expected to improve vascular health. Furthermore, Hudthagosol 
et al. showed that 90 g of whole pecans or 90 g of blended pecans increased postprandial plasma levels 
of phenolic acid and flavanols, increased antioxidant capacity and decreased LDL-cholesterol oxidation, 
compared to an isocaloric macronutrient matched meal (Hudthagosol et al., 2011). In this study, vascular 
health was not measured. However, based on the increase in total plasma phenolic acid and flavanols is 
it likely that endothelial function would have been greater (improved) after consumption of the pecan-
containing meals compared with the control meal.  
Previous work from our lab has shown that foods rich in phenolic compounds exert health effects beyond 
those expected based on the macronutrient profile. For example, in a randomized, crossover controlled 
feeding study, a moderate fat diet (34% fat, 6% SFA, 17% MUFA, 9% PUFA, 49% CHO, 16% PRO) containing 
one-avocado per day lowered atherogenic lipids and lipoproteins more than a matched moderate fat diet 
without avocado (Wang, Bordi, Fleming, Hill, & Kris‐Etherton, 2015). Specifically, the moderate fat diet 
containing one-avocado per day lowered LDL-cholesterol and non-HDL cholesterol (−13.5 mg/dL, −14.6 
mg/dL), relative to baseline and to a greater extent (P<0.05) than the matched moderate fat diet devoid 
of avocado (−8.3 mg/dL, −8.7 mg/dL) and a low fat (LF; −7.4 mg/dL, −4.8 mg/dL) control diet. The greater 
improvements in lipids and lipoproteins with the moderate-fat diet containing avocado vs. the matched 
moderate-fat diet without avocado suggests beneficial effects beyond the fatty acid profile of the 
avocado; it is hypothesized that the bioactive compounds and the fiber content of avocados may explain 
the results of this previous study. 


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Similarly, in a randomized, crossover controlled feeding study comparing a heart healthy diet with walnuts 
to a fatty acid matched diet devoid of walnuts, and a diet lower in alpha-linoleic acid (ALA) and 
proportionately higher in oleic acid, we observed greater total cholesterol and LDL-cholesterol lowering 
(unpublished) and a greater reduction in aortic diastolic blood pressure (A. M. Tindall et al., 2019) with 
the walnut containing heart healthy diet vs. the low ALA diet; no difference was detected between the 
walnut containing diet and the fatty acid matched diet devoid of walnuts, and the fatty acid matched diet 
devoid of walnuts and the low ALA diet. This suggests that the fatty acid component of walnuts may not 
explain the full effect that we observed.  
Based on these studies, we hypothesize that greater improvements in risk factors for cardiometabolic 
disease will be observed with incorporation of pecan into and average American diets vs. the typical U.S. 
diet. This research aligns with the current focus on food-based recommendations, by authoritative 
organizations, because of the inherent limitations associated with nutrient-focused recommendations. 
Furthermore, evidence generated may be used to support food-based recommendations for pecans, and 
since 2 oz/day (14 oz-eq/week) of pecans will be provided, the findings may be used to support higher 
intake recommendations for nuts, specifically pecans. The 2020-2025 Dietary Guidelines for Americans 
recommends (5 oz.-eq/week of nuts, seeds and soy at 2000 kcal). 
 
2.2 
Previous Data 
Describe any relevant preliminary data. 
 
Previous work from our lab has shown that foods rich in phenolic compounds exert health effects beyond 
those expected based on the macronutrient profile (Wang et al., 2015). In another randomized, crossover 
controlled feeding study comparing a heart healthy diet with walnuts to a fatty acid matched diet devoid 
of walnuts, and a diet lower in alpha-linoleic acid (ALA) and proportionately higher in oleic acid, we 
observed greater total cholesterol and LDL-cholesterol lowering and a greater reduction in aortic diastolic 
blood pressure (A. M. Tindall et al., 2019) with the walnut containing heart healthy diet vs. the low ALA 
diet; no difference was detected between the walnut containing diet and the fatty acid matched diet 
devoid of walnuts, and the fatty acid matched diet devoid of walnuts and the low ALA diet. This suggests 
that the fatty acid component of walnuts may not explain the full effect that we observed.  
A significant proportion of the polyphenol content is flavanols (494 mg/100g), which are present in pecans 
in higher quantities than dark chocolate (246 mg/100g), blueberries (332 mg/100g) and red wine (313 
mg/100g) (Gu et al., 2004). A meta-analysis of 11 studies showed that flow mediated dilation (FMD), a 
measure of endothelial function, increased by 1.34% after 2-18 weeks of consuming 
chocolate/cocoa/flavanols (Hooper et al., 2012). 
Based on these studies, we hypothesize that greater improvements in risk factors for cardiometabolic 
disease will be detected following consumption of the average American diet with pecans versus typical 
US dietary intake. 
 
2.3 
Study Rationale 
Provide the scientific rationale for the research. 
 
A study with this design would provide the first empirical evidence to directly support the inclusion of 
pecans in a recommended healthy dietary pattern. In addition to providing evidence about the 
cardiometabolic effects of using pecans to improve the diet quality of an average American diet, this 
study will provide a feasible food-based approach that may be used to lower CVD risk. 
 
Approximately, 50% of Americans are at risk for CVD (29) and therefore, the findings from this study will 
be of direct relevance to many Americans. Specifically, the results will be of interest to individuals who 
are managing their elevated CVD risk with lifestyle strategies and pharmacotherapy; this study will test 
another lifestyle strategy that can be implemented to lower CVD risk. 


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The findings of this trial utilizing a non-pharmaceutical approach will be applicable to overweight and 
obese adults living with one or more symptoms of metabolic syndrome and are therefore at increased 
risk of cardiovascular disease in the US, and thus will be of substantial public interest. 
3.0 
Inclusion and Exclusion Criteria 
Create a numbered list below in sections 3.1 and 3.2 of criteria subjects must meet to be eligible for study 
enrollment (e.g., age, gender, diagnosis, etc.).  
 
Vulnerable Populations: 
 
Indicate specifically whether you will include any of the following vulnerable populations in this research. You 
MAY NOT include members of these populations as subjects in your research unless you indicate this in your 
inclusion criteria because specific regulations apply to studies that involve vulnerable populations.   
 
The checklists referenced below outline the determinations to be made by the IRB when reviewing research 
involving these populations. Review the checklists as these will help to inform your responses throughout the 
remainder of the protocol. 
 
• 
Children –Review “HRP-416- Checklist - Children” 
• 
Pregnant Women – Review “HRP-412- Checklist - Pregnant Women” 
• 
Cognitively Impaired Adults- Review “HRP-417- Checklist - Cognitively Impaired Adults”  
• 
Prisoners- Review “HRP-415- Checklist - Prisoners” 
• 
Neonates of uncertain viability or non-viable neonates- Review “HRP-413- Checklist - Non-Viable 
Neonates” or “HRP-414- Checklist - Neonates of Uncertain Viability” 
[Do not type here] 
 
3.1 
Inclusion Criteria 
Create a numbered list of the inclusion criteria that define who will be included in your final study 
sample (e.g., age, gender, condition, etc.)  
 
1) 25-70 years of age 
2) BMI 25-40 kg/m2 
3) ≥ 1 criterion for metabolic syndrome (i.e., waist circumference ≥ 94 cm men or ≥ 80 cm women; 
triglycerides ≥150 mg/dL; HDL-cholesterol ≤ 40 mg/dL men or ≤ 50 mg/dL women; systolic blood 
pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at 
screening. 
 
 
 
 
 
3.2 
Exclusion Criteria 
Create a numbered list of the exclusion criteria that define who will be excluded in your study. 
 
1) Current use of tobacco-containing products or (≤6 months) cessation  
2) Allergy/sensitivity/intolerance/dislike of study foods 
3) Women who are pregnant, lactating, planning to become pregnant or have given birth in the 
past year 


Page 9 of 45 (IRB USE ONLY: V. 03/01/2021)  
4) Individuals who have had a cardiovascular event (heart attack, revascularization, stroke), or 
have a history of heart failure, liver, kidney, autoimmune diseases or inflammatory conditions 
such as gastrointestinal disorders or rheumatoid arthritis. 
5) Type 1 or type 2 diabetes 
6) Unstable weight ≥10% body weight for 6 months prior to enrollment 
7) Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg at screening 
8) Fasting blood glucose ≥126 mg/dL at screening 
9) Triglycerides ≥350 mg/dL at screening 
10) Taking any medications known to affect lipids, blood pressure, or blood glucose levels 
11) Diagnosed inflammatory conditions or taking prescribed anti-inflammatory medications  
12) Use of antibiotics within the prior 8 weeks 
13) Taking supplements (e.g., psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals 
known to affect study outcomes and not willing to cease for the duration of the study 
14) Individuals consuming >14 alcoholic drinks/week, and not willing to avoid alcohol consumption 
for 48 hours prior to test visit 
15) Pre-menopausal women who do not have a regular menstrual cycle of 25-35 days 
16) PI discretion  
 
3.3 
Early Withdrawal of Subjects 
3.3.1 
Criteria for removal from study 
Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol 
requirements, subject consent withdrawal, disease progression, etc.). 
 
Failure to comply with study procedures.   
Participant withdraws consent. 
 
3.3.2 
Follow-up for withdrawn subjects 
Describe when and how to withdraw subjects from the study; the type and timing of the data to 
be collected for withdrawal of subjects; whether and how subjects are to be replaced; the 
follow-up for subjects withdrawn from investigational treatment. 
 
 
No safety concerns; no reason for follow-up. If consent is withdrawn no data from the 
participant will be used. Otherwise, if consent is not withdrawn, data from individuals who 
withdraw from the study may be used in an intent-to-treat analysis but another individual will 
be enrolled for each participant who drops out to ensure that an adequate sample size (with 
complete data) is reached. 
4.0 
Recruitment Methods 
▪ Upload recruitment materials for your study in CATS IRB (http://irb.psu.edu).  DO NOT include the actual 
recruitment wording in this protocol.   
▪ StudyFinder:  If StudyFinder (http://studyfinder.psu.edu) is to be used for recruitment purposes, separate 
recruitment documents do not need to be uploaded in CATS IRB. The necessary information will be captured 
from the StudyFinder page in your CATS IRB study.   
▪ Any eligibility screening questions (verbal/phone scripts, email, etc.) used when contacting potential 
participants must be uploaded to your study in CATS IRB (http://irb.psu.edu). 
[Do not type here] 
 


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4.1 
Identification of subjects 
Describe the source of subjects and the methods that will be used to identify potential subjects (e.g., 
organizational listservs, established recruitment databases, subject pools, medical or school records, 
interactions during a clinic visit, etc.).   If not recruiting subjects directly (e.g., database query for eligible 
records or samples) state what will be queried, how and by whom. 
 
StudyFinder:   
o If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, include this 
method in this section.  
o Information provided in this protocol needs to be consistent with information provided on the 
StudyFinder page in your CATS IRB study. 
 
For Penn State Health submissions using Enterprise Information Management (EIM) for recruitment, and 
for non-Hershey locations as applicable, attach your EIM Design Specification form on in CATS IRB 
(http://irb.psu.edu). See “HRP-103- Investigator Manual, What is appropriate for study recruitment?” 
for additional information. DO NOT include the actual recruitment material or wording in this protocol. 
 
Flyer/posters will be placed in campus buildings and facilities as well as the surrounding area (gyms, 
churches, supermarkets, coffee shops, offices of health care providers etc.) to identify potential subjects 
residing in and around the State College. Ads will also be placed in the local papers, magazines (e.g., 
Centre Daily Times) and coupon mailers (e.g. Valpak), which are distributed to residential homes. In 
addition, radio ads will be run. Websites (e.g. http://clinicaltrials.gov/, Facebook, Craig's List, 
StudyFinder), and PSU listservs will be used to advertise the study. We will register for and utilize PALS 
database to contact participants as well. We also will contact individuals who have participated in 
previous studies and indicated to our research group that they are interested in participating in future 
studies. A letter to local businesses or organization may be utilized requesting they share study details 
with their members/employees if permitted. 
 
4.2 
Recruitment process 
Describe how potential subjects first learn about this research opportunity or indicate as not applicable 
if subjects will not be prospectively recruited to participant in the research.  Subject recruitment can 
involve various methods (e.g., approaching potential subjects in person, contacting potential subjects via 
email, letters, telephone, ResearchMatch, or advertising to a general public via flyers, websites, 
StudyFinder, newspaper, television, and radio etc.). DO NOT include the actual recruitment material or 
wording in this protocol. 
[Do not type here] 
 
4.2.1 
How potential subjects will be recruited. 
Public advertisements (flyers/posters/ newspaper ads/circulars/ websites and social media/ 
radio/listservs) in the local community (State College/ University Park area)  
A letter to local businesses or organizations requesting they share study details with their 
members/employees e.g. gyms, health clubs, social organizations, businesses located downtown 
or in the surrounding area.   
StudyFinder  
Telephone or email will be used to contact individuals who have participated in previous studies 
and indicated to our research group that they are interested in participating in future studies 
People who are in the PALS database will be contacted using the verbiage in document 
PALS_Statement.doc(0.01)  
4.2.2 
Where potential subjects will be recruited. 
University Park and State College PA and surrounding areas.   


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4.2.3 
When potential subjects will be recruited. 
As soon as the protocol is IRB approved, recruitment will commence and continue until the 
target sample size is enrolled.   
 
4.2.4 
Describe the eligibility screening process and indicate whether the screening process will 
occur before or after obtaining informed consent. Screening begins when the investigator 
obtains information about or from a prospective participant in order to determine their 
eligibility.  In some studies, these procedures may not take place unless HIPAA Authorization 
is obtained OR a waiver of HIPAA Authorization when applicable for the screening procedures 
is approved by the IRB.  [For FDA regulated studies, consent for any screening activities would 
need to be obtained prior to screening unless specifically waived by the IRB.] 
 
Verbal screening consent will be obtained prior to the telephone screening being conducted. 
During the telephone screening a brief description of the study will be provided and the subject 
will provide vfloerbal consent to answer screening questions. If the individual agrees, some 
preliminary screening questions will be asked to establish whether the person is likely eligible 
for the study. If they are, a screening appointment will be scheduled at the Clinical Research 
Center (CRC).  At this appointment, before any procedures take place, written informed consent 
will be obtained. 
5.0 
Consent Process and Documentation  
Refer to the following materials: 
• 
The “HRP-090- SOP - Informed Consent Process for Research” outlines the process for obtaining informed 
consent.   
• 
The “HRP-091– SOP - Written Documentation of Consent” describes how the consent process will be 
documented. 
• 
The “HRP-314- Worksheet - Criteria for Approval” section 7 lists the required elements of consent. 
• 
The “HRP-312- Worksheet - Exemption Determination” includes information on requirements for the 
consent process for exempt research.  In addition, the CATS IRB Library contains consent guidance and 
templates for exempt research. 
• 
The CATS IRB library contains various consent templates for expedited or full review research that are 
designed to include the required information. 
• 
Add the consent document(s) to your study in CATS IRB (http://irb.psu.edu). Links to Penn State’s consent 
templates are available in the same location where they are uploaded. DO NOT include the actual consent 
wording in this protocol. 
[Do not type here] 
 
5.1 
Consent Process: 
Check all applicable boxes below: 
 
 Informed consent will be sought and documented with a written consent form [Complete Sections 
5.2 and 5.6]  
 
 Implied or verbal consent will be obtained – subjects will not sign a consent form (waiver of 
written documentation of consent) [Complete Sections 5.2, 5.3 and 5.6]  
 
  Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). [Complete section 5.2, 5.4 and 5.6]  
 


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 Informed consent will not be obtained – request to completely waive the informed consent 
requirement. [Complete Section 5.5] 
 
 
The following checkbox is for all locations EXCEPT Penn State Health and College of Medicine:  
 
 
 Exempt Research at all Locations Except Penn State Health and the College of Medicine: If you 
believe that the research activities outlined meet one or more of the criteria outlined in “HRP-312- 
Worksheet- Exemption Determination.” Please verify by checking this box that if conducting an 
exempt research study, the consent process will disclose the following (all of which are included in 
“HRP-590- Consent Guidance for Exempt Research”): 
 
Penn State affiliation; name and contact information for the researcher and advisor (if the 
researcher is a student); the activities involve research; the procedures to be performed; 
participation is voluntary; that there are adequate provisions to maintain the privacy interests of 
subjects and the confidentiality of the data; and subjects may choose not to answer specific 
questions.   
 
 
If the research includes the use of student educational records include the following language in 
this section (otherwise delete): The parent or eligible student will provide a signed and dated 
written consent that discloses: the records that may be disclosed; the purpose of the disclosure; the 
party or class of parties to whom the disclosure may be made; if a parent or adult student requests, 
the school will provide him or her with a copy of the records disclosed; if the parent of a student 
who is not an adult so requests, the school will provide the student with a copy of the records 
disclosed. 
 
 
Note: If this box has been checked, skip the remainder of section 5 and proceed to section 6 of this 
protocol. If the investigator’s assessment is inaccurate, an IRB Analyst will request revision to the 
protocol and that an informed consent form be submitted for review and approval. Except for 
exemptions where Limited IRB Review (see “HRP-312- Worksheet- Exemption Determination”) is 
required or where otherwise requested by the IRB, informed consent forms for research activities 
determined to be exempt without Limited IRB Review are generally not required to be submitted 
for review and approval by the University Park IRB.  
 
 
5.2 
Obtaining Informed Consent  
5.2.1 
Timing and Location of Consent  
Describe where and when the consent process will take place. 
 
Verbal consent will be obtained prior to the telephone screening in a private room at Chandlee 
Laboratory or in a private room at the Clinical Research Center, Noll Laboratory.   
  
Informed consent will be obtained at the Clinical Research Center, Noll Laboratory in a private 
room at the screening appointment prior to any screening procedures taking place. 
5.2.2 
Coercion or Undue Influence during Consent  
Describe the steps that will be taken to minimize the possibility of coercion or undue influence 
in the consent process. 
 
Study staff, coordinators, and investigators who are fully trained in the recruiting process will 
respond to potential participants during recruitment so as to avoid any coercion or undue 
influence.  
 


Page 13 of 45 (IRB USE ONLY: V. 03/01/2021)  
Participation is voluntary and participants can withdraw at any time. Participants will be 
emailed a copy of the written consent form, at the time their screening appointment is 
scheduled, and be asked to read it prior to their visit. At the screening visit, a study coordinator 
will ask the participant if they had a chance to read the consent form prior to the visit. If not, 
they will be given time to read the written consent form. A study coordinator will then go 
through the written consent form with the participant, allowing time for the participant to ask 
questions throughout.  
 
 
5.3 
Waiver of Written Documentation of Consent  
Review “HRP – 411 – Checklist – Waiver of Written Documentation of Consent.”  
 
 
 
5.3.1 
Indicate which of the following conditions applies to this research: 
  The research presents no more that minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context. 
OR 
  The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether the subject wants documentation linking the subject with the research, 
and the subject’s wishes will govern. (Note: This condition is not applicable for FDA-regulated 
research. If this category is chosen, include copies of a consent form and /or parental 
permission form for participants who want written documentation linking them to the 
research.) 
OR 
  If the subjects or legally authorized representatives are members of a distinct cultural group 
or community in which signing forms is not the norm, that the research presents no more 
than minimal risk of harm to subjects and provided there is an appropriate alternative 
mechanism for documenting that informed consent was obtained.  (Note: This condition is not 
applicable for FDA-regulated research.)  
 
Describe the alternative mechanism for documenting that informed consent was obtained: 
 
Not applicable 
 
5.3.2 
Indicate what materials, if any, will be used to inform potential subjects about the research 
(e.g., a letter accompanying a questionnaire, verbal script, implied consent form, or summary 
explanation of the research) 
 
Verbal Script see uploaded Verbal Consent 6-18-21. 
 
5.4 
Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). 
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided 
sufficient information.   
 
5.4.1 
Indicate the elements of informed consent to be omitted or altered 
 


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Not applicable 
 
5.4.2 
Indicate why the research could not practicably be carried out without the omission or 
alteration of consent elements 
 
Not applicable 
 
5.4.3 
Describe why the research involves no more than minimal risk to subjects. 
 
Not applicable 
 
5.4.4 
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects. 
 
Not applicable 
 
5.4.5 
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format. 
 
Not applicable 
 
5.4.6 
Debriefing  
Explain whether and how subjects will be debriefed after participation in the study. If subjects 
will not be debriefed, provide a justification for not doing so.  Add any debriefing materials to 
the study in CATS IRB. 
 
Not applicable 
 
 
5.5 
Informed consent will not be obtained – request to completely waive the informed consent 
requirement 
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided 
sufficient information. 
 
5.5.1 
Indicate why the research could not practicably be carried out without the waiver of consent 
 
Not applicable 
 
5.5.2 
Describe why the research involves no more than minimal risk to subjects. 
 
Not applicable 
 


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5.5.3 
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects. 
 
Not applicable 
 
5.5.4 
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format. 
 
Not applicable 
 
5.5.5 
Additional pertinent information after participation 
Explain if subjects will be provided with additional pertinent information after participation. If 
not applicable, indicate “not applicable.”    
 
Not applicable 
 
 
 
5.6 
Consent – Other Considerations  
 
5.6.1 
Non-English-Speaking Subjects 
Indicate what language(s) other than English are understood by prospective subjects or 
representatives. 
 
If subjects who do not speak English will be enrolled, describe the process to ensure that the 
oral and written information provided to those subjects will be in that language. Indicate the 
language that will be used by those obtaining consent. 
 
Indicate whether the consent process will be documented in writing with the long form of the 
consent documentation or with the short form of the consent documentation.  Review “HRP-
091 –SOP- Written Documentation of Consent” and “HRP-103 -Investigator Manual” to ensure 
that you have provided sufficient information.  
 
Prospective subjects who do not understand English will not be enrolled. 
 
5.6.2 
Cognitively Impaired Adults 
Refer “HRP-417 -CHECKLIST- Cognitively Impaired Adults” for information about research 
involving cognitively impaired adults as subjects.  
 
5.6.2.1 Capability of Providing Consent 
Describe the process to determine whether an individual is capable of consent. 
 
Not applicable 
 
5.6.2.2 Adults Unable to Consent 
Describe whether and how informed consent will be obtained from the legally 
authorized representative.  Describe who will be allowed to provide informed 
consent. Describe the process used to determine these individual’s authority to 
consent to research. 


Page 16 of 45 (IRB USE ONLY: V. 03/01/2021)  
 
For research conducted in the state of Pennsylvania, review “HRP-013 -SOP- Legally 
Authorized Representatives, Children and Guardians” to be aware of which 
individuals in the state of Pennsylvania meet the definition of “legally authorized 
representative.” 
 
For research conducted outside of the state of Pennsylvania, provide information 
that describes which individuals are authorized under applicable law to consent on 
behalf of a prospective subject to their participation in the procedure(s) involved in 
this research.  One method of obtaining this information is to have a legal counsel or 
authority review your protocol along with the definition of “children” in “HRP-013 -
SOP- Legally Authorized Representatives, Children, and Guardians.” 
 
Not applicable 
 
5.6.2.3 Assent of Adults Unable to Consent 
Describe the process for assent of the subjects.  Indicate whether assent will be 
required of all, some or none of the subjects.  If some, indicate which subjects will 
be required to assent and which will not.  
 
If assent will not be obtained from some or all subjects, provide an explanation of 
why not. 
 
Describe whether assent of the subjects will be documented and the process to 
document assent.  The IRB allows the person obtaining assent to document assent 
on the consent document and does not routinely require assent documents and 
does not routinely require subjects to sign assent documents. 
 
Not applicable 
 
5.6.3 
Subjects who are not yet adults (infants, children, teenagers)  
 
5.6.3.1 Parental Permission 
Describe whether and how parental permission will be obtained. If permission will 
be obtained from individuals other than parents, describe who will be allowed to 
provide permission.  Describe the process used to determine these individual’s 
authority to consent to each child’s general medical care. 
 
For research conducted in the state of Pennsylvania, review “HRP-013-SOP- Legally 
Authorized Representatives, Children and Guardians” to be aware of which 
individuals in the state of Pennsylvania meet the definition of “children.”  
 
For research conducted outside of the state of Pennsylvania, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved in the research, under the applicable law of the 
jurisdiction in which research will be conducted.  One method of obtaining this 
information is to have a legal counsel or authority review your protocol along with 
the definition of “children” in “HRP-013-SOP- Legally Authorized Representatives, 
Children, and Guardians.” 
 


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Not applicable 
 
5.6.3.2 Assent of subjects who are not yet adults 
Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be required 
to assent. When assent of children is obtained describe whether and how it will be 
documented. 
 
Not applicable 
 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually 
identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted 
or maintained in any form or medium by a Covered Entity or its Business Associate. A Covered Entity is a health 
plan, a health care clearinghouse or health care provider who transmits health information in electronic form.  
See “HRP-103 -Investigator Manual” for a list of the 18 identifiers.   
 
If requesting a waiver/alteration of HIPAA authorization, complete sections 6.2 and 6.3 in addition to section 
6.1. The Privacy Rule permits waivers (or alterations) of authorization if the research meets certain conditions. 
Include only information that will be accessed with the waiver/alteration.  
[Do not type here] 
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 
 
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
6.2.1.1 
Plan to protect PHI from improper use or disclosure 
Include the following statement as written – DO NOT ALTER OR DELETE 
unless this section is not applicable because the research does not involve a 


Page 18 of 45 (IRB USE ONLY: V. 03/01/2021)  
waiver of authorization. If the section is not applicable, remove the 
statement and indicate as not applicable.  
 
Information is included in the “Confidentiality, Privacy and Data 
Management” section of this protocol. 
 
6.2.1.2 
Plan to destroy identifiers or a justification for retaining identifiers  
Describe the plan to destroy the identifiers at the earliest opportunity 
consistent with the conduct of the research. Include when and how 
identifiers will be destroyed. If identifiers will be retained, provide the legal, 
health or research justification for retaining the identifiers. 
 
Not applicable 
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
Provide an explanation for why the research could not practicably be conducted without access 
to and use of PHI. 
 
Not applicable 
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
Provide an explanation for why the research could not practicably be conducted without the 
waiver or alternation of authorization. 
 
Not applicable 
 
 
 
6.3 
Waiver or alteration of authorization statements of agreement 
 
By submitting this study for review with a waiver of authorization, you agree to the following statement – 
DO NOT ALTER OR DELETE unless this section is not applicable because the research does not involve a 
waiver or alteration of authorization. If the section is not applicable, remove the statement and indicate 
as not applicable. 
 
Not applicable. 
 
7.0 
Study Design and Procedures 
Data collection materials that will be seen or used by subjects in your study must be uploaded to CATS IRB 
(http://irb.psu.edu).   DO NOT include any actual data collection materials in this protocol (e.g., actual survey or 
interview questions) 
 
[Do not type here] 
 
7.1 
Study Design 
Describe and explain the study design. 
 


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A two-arm randomized parallel study is proposed. Subjects will be randomized to one of the following 
attention and resource matched conditions for approximately 12-weeks: 1) education to consume 2 
oz./day of pecans in place of the snacks they usually eat (AAD+P); 2) continue consuming their current 
diet (AAD) with provision gift cards worth $30 monthly (equivalent value to the pecans) and matched 
contact with study personnel. 
 
Assessment of outcomes will occur at baseline and the end of the treatment period (week 12). Pre-
menopausal women will be scheduled for testing within 7 days of starting their menstrual period to 
control for hormonal effects on vascular function. Therefore, the treatment periods may be adjusted as 
needed. At the baseline and 12-weeks two blood samples will be collected (separated by at least 24-
hours) for endpoint analysis. Weight will be measured on both days at each timepoint. Flow mediated 
dilation, central and peripheral blood pressure and pulse wave velocity will be measured on one day at 
each time point. Diet intake will be assessed at baseline, week 6, and week 12 using 24-hour recalls. 
Subjects will also provide a fecal collection at baseline and 12 weeks. 
 
 
7.2 
Study Procedures 
Provide a step by step description of all research procedures being conducted (broken down by visit, if 
applicable) including such information as below (where and when applicable); describe the following: 
• 
HOW: (e.g., data collection via interviews, focus groups, forms such as surveys and questionnaires, 
medical/school records, audio/video/digital recordings, photographs, EKG procedures, MRI, mobile 
devices such as electronic tablets/cell phones, observations, collection of specimens, experimental 
drug/device testing, manipulation of behavior/use of deception, computer games, etc.) 
• 
WHERE: (e.g., classrooms, labs, internet/online, places of business, medical settings, public spaces, 
etc.) 
 
 [Type protocol text here] 
 
7.2.1 
Visit 1 or Day 1 or Pre-test, etc.  
Provide a description of what procedures will be performed on visit 1 or day 1 or pre-test in 
order of how these will be done.  If your study only involves one session or visit, use this section 
only and indicate 7.2.2 as not applicable.  
 
Participants will be consented prior to any screening activities. 
Screening: This visit will occur at the Clinical Research Center, Noll Laboratory. The clinical visit 
will consist of filling out forms (medical history, personal information); measuring waist 
circumference and height and weight so that BMI can be calculated and blood pressure will be 
measured to determine eligibility. Women of child-bearing potential will provide a urine sample 
for a pregnancy test. A blood sample will be taken and a complete blood count, and a blood lipid 
panel will be performed (approximately 19 ml of blood or ~1.25 tablespoon will be taken). If the 
initial blood draw is unsuccessful it may need to be repeated, with permission from the 
participant. In addition, if a potential participant takes thyroid medicine they must provide a 
current (within 6 months) lab test. If they do not have one, an extra 3.5 ml (0.2 Tbsp) of blood 
will be taken to conduct a thyroid test. If all eligibility criteria are met, participants will be 
scheduled for their baseline measurements. Baseline visits typically occur within 1-2 weeks 
following the screening appointment. Participants will be provided with one of two standardized 
meals with foods commonly consumed in the American diet prepared in the metabolic diet 
center kitchen to consume the evening before their Day 2 visit. The meal options will be 
Mediterranean chicken with potatoes and broccoli OR a black bean quesadilla with broccoli.  
 


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7.2.2 
Visit 2 or Day 2 or Post-test, etc. (If applicable)  
Provide a description of what procedures will be performed on visit 2 or day 2 or post-test in 
order of how these will be done.  If your study involves more than two sessions or visits 
replicate this section for each additional session or visit (e.g., 7.2.3, 7.2.4, etc.).  
 
*Vascular testing may occur on day 1 or day 2 based on participant’s availability 
 
Baseline and Endpoint Measurements (Day 1) 
Measures will be collected at baseline and 12 weeks. At each timepoint, fasting blood samples 
will be collected for analysis of biochemical endpoints. Body weight will be taken, and vascular 
health assessments will be performed at baseline and week 12. Participants will also complete a 
fecal collection at the beginning and end of the treatment period. Participants will complete 
three, 24-hour dietary recalls at baseline, week 6 and week 12 for a total of 9 dietary recalls. 
Participants will be provided a standardized meal for dinner. 
 
 
Central and peripheral blood pressure: Following a 5-minute rest period, brachial artery systolic 
and diastolic blood pressure will be measured in the left arm using an automated blood pressure 
cuff. The cuff will reinflate and obtain a pulse wave form. Central blood pressure and wave 
reflection characteristics (augmentation index) will then be derived from the pressure 
waveforms using a validated transfer function with a SphygmoCor System (AtCor Medical, 
Sydney, Australia). This test will be performed in triplicate. 
 
Pulse Wave Velocity:  Arterial stiffness will be assessed by calculating the pulse wave velocity 
(PWV) between the carotid and femoral arteries while in the supine position. A cuff will be 
placed on the participant's thigh. The cuff will inflate during the test to record the pulse 
waveform in the femoral artery. A simultaneous measurement of the carotid artery pressure 
waveform will be obtained by an applanation tonometry sensor manually held in place above 
the carotid artery. PWV will subsequently be calculated by dividing the linear distance between 
the carotid and femoral sites by the transit time using the SphygmoCor system (AtCor Medical, 
Sydney Australia). This measurement will be performed in triplicate. 
 
Plasma/serum analysis: In addition to the blood taken at screening, 12 hour fasting blood 
samples also will be taken. Approximately 45 ml (about 3 Tbsp) will be collected at each visit. A 
typical American Red Cross blood donation is 1 pint (500 ml). Blood may be analyzed for the 
following: blood lipids and lipoprotein concentration, particle number and size, glucose and 
insulin, other markers of glycemia, cholesterol metabolism, and/or inflammation.  
 
Fecal collection: At baseline and the end of each treatment period, participants will be asked to 
collect a stool sample (~50 g). They will be provided with a stool sample kit and detailed 
instructions for collection of a clean sample on Day 1 of testing and asked to bring in the 
collected sample on Day 2; if an individual is not able collect the sample within this timeframe 
alternative arrangements will be made to accommodate the subject. Fecal samples will be 
analyzed for gut bacteria composition (gut microbiome).  
 
7.2.3 Day 2 of Baseline and Endpoint Measures 
On day 2 of baseline and endpoint visits, which occur approximately 24 hours after day 1 
testing, a fasting blood sample will be collected and flow mediated dilation measures will be 
taken. Body weight will be taken. Fecal sample collection will be brought to the visit by the 
subject. 
 


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Flow mediated dilation: Study subjects will undergo endothelial health assessment by FMD at 
baseline (beginning of study) and end of each intervention period. The technique of FMD is a 
non-invasive test that assesses endothelium-dependent dilatation in response to increased 
blood flow. Blood flow is induced by inflation and deflation of a cuff on the forearm. The cuff 
should be inflated to suprasystolic pressures in order to occlude the brachial artery. A pressure 
of 250 mmHg is a standard pressure used by many research groups. B-mode ultrasound is used 
to assess endothelium-dependent vasodilation. 
 
Plasma/serum analysis: A 12 hour fasting blood sample will be taken. Approximately 45 ml 
(about 3 Tbsp) will be collected at each visit. A typical American Red Cross blood donation is 1 
pint (500 ml). Blood may be analyzed for the following: blood lipids and lipoprotein 
concentration, particle number and size, glucose and insulin, other markers of glycemia, 
cholesterol metabolism, and/or inflammation.  
 
7.2.4 Monthly study food or gift card 
Monthly, participants will coordinate pick up times for study food or gift card with study 
personnel at Penn State Metabolic Diet Study Center. Depending on Group, the script on “Usual 
Care Group Instructions-Marcella-6-18-21” or “Pecan Group Instructions-Marcella-6-18-21” will 
be used. Participants will also return compliance tracking sheets at months 2 and 3 (see 
attached “Daily monitoring form pecan condition-6-18-2021” or “Daily monitoring for usual care 
condition-6-18-2021) to identify if/when and how the pecans are being consumed. 
 
Daily monitoring form: Participants will complete daily monitoring forms regarding consumption 
of pecans (test food)/ food consumed during the usual care condition, changes in medication or 
health during the study. When they pick up their test food monthly, they will be provided with 
the daily monitoring forms and asked to return the completed forms the next time they pick up 
food. Participants will also receive a phone call biweekly to ensure compliance. 
7.2.5 24-hour dietary recalls 
Dietary intake: Three, 24-hour recalls will be administered in the week prior to baseline, week 6, 
and week 12 of the study using the Automated Self-Administered 24-Hour (ASA24®) Dietary 
Assessment Tool. This is an online system where participants will provide information about all 
foods, beverages and supplements consumed during the previous day. This system generates 
food group and nutrient data from the 24- hour recalls. These data will be used for calculation of 
diet quality assessed by the Healthy Eating Index 2015 (4). 
 
7.3 
Duration of Participation 
Describe how long subjects will be involved in this research study.  Include the number of sessions and 
the duration of each session - consider the total number of minutes, hours, days, months, years, etc.   
 
Each participant will be involved in the study for approximately 12 weeks. Pre-menopausal women will 
be scheduled for testing within 7 days of starting their menstrual period to control for hormonal effects 
on vascular function; the treatment period will be adjusted accordingly in pre-menopausal women. 
Participants will be expected to pick up the pecans/gift card monthly at the diet center on campus. 
Participants will remain in their vehicle and a staff member from the Metabolic Diet Center will bring 
pecans/gift cards Compliance monitoring will also be conducted at this appointment. At the beginning 
and end of the diet period, data collection (described above) will occur.   
 
Total time for study visits, after the initial screening is approximately 3 hours. Times may vary and 
females will require an additional 5 minutes for a urine pregnancy test a baseline and the end of the diet 
period. The following is an estimate of the amount of time participants will spend in study activities:  
 
 


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Screening appointment:   
 
Day 1: Forms, blood pressure, weight, height, waist circumference, blood draw – 45-60 minutes  
 
(pregnancy testing: females only – 5 minutes)  
 
Beginning of treatment period: 
Day 1: blood draw, weight, waist circumference, vascular testing– 60 minutes   
 
(pregnancy testing: females only – 5 minutes)  
 
Day 2: blood draw, vascular testing – 45 minutes   
 
End of treatment period (week 12):  
Day 1: blood draw, weight, waist circumference, vascular testing– 60 minutes   
 
(pregnancy testing: females only – 5 minutes)  
 
Day 2: blood draw, vascular testing – 45 minutes   
 
 
Picking up food/gift card, fecal collections, and completing 24-hour diet recalls: ~ 7 hours  
  
 
Total time for clinic and diet center visits from the beginning to the end of the study ~12 hours   
 
8.0 
Number of Subjects and Statistical Plan 
 
8.1 
Number of Subjects 
Indicate the maximum number of subjects to be accrued/enrolled. Distinguish between the number of 
subjects who are expected to be enrolled and screened, and the number of subjects needed to 
complete the research procedures if applicable (i.e., numbers of subjects excluding screen failures.) 
 
A sample size of 128 (64 per group) is needed. To complete 128 individuals, approximately 140 
participants will be recruited to account for an anticipated ~10% dropout rate. 
 
8.2 
Sample size determination 
If applicable, provide a justification of the sample size outlined in section 8.1  to include reflections on, 
or calculations of, the power of the study. 
 
Power analysis for the primary endpoint, FMD, is based on the differences reported in clinical trials of 
tree nuts (5-8). To detect a 1.2% (standard deviation 2.4; effect size 0.5) between-condition mean 
difference with 80% power (α=0.05), 128 or 64 people per group are needed. 
 
8.3 
Statistical methods 
Describe the statistical methods (or non-statistical methods of analysis) that will be employed. 
 
The normality of the data will be tested before performing analyses, and transformations will be made if 
needed. In the primary analyses, the change in outcome measures (baseline to 12 weeks) will be 
compared between groups after adjustment for baseline value, age, sex, and BMI. The mixed model 


Page 23 of 45 (IRB USE ONLY: V. 03/01/2021)  
procedure will be used (SAS) with randomization as a fixed factor, and baseline value for the outcome 
measure, age, sex, and BMI included as covariates. 
9.0 
Data and Safety Monitoring Plan 
This section is required when research involves more than Minimal Risk to subjects as defined in “HRP-001 
SOP- Definitions.” 
 
Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the research that 
are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests.  For research involving prisoners, Minimal Risk is the 
probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in 
the routine medical, dental, or psychological examination of healthy persons.  
 
Please complete the sections below if the research involves more than minimal risk to subjects, otherwise 
indicate each section as not applicable.  
[Do not type here] 
 
9.1 
Periodic evaluation of data 
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe. 
 
Not applicable 
 
9.2 
Data that are reviewed 
Describe the data that are reviewed, including safety data, untoward events, and efficacy data. 
 
Not applicable 
 
9.3 
Method of collection of safety information 
Describe the method by which the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls and with subjects). 
 
Not applicable 
 
9.4 
Frequency of data collection 
Describe the frequency of data collection, including when safety data collection starts. 
 
Not applicable 
 
9.5 
Individuals reviewing the data 
Identify the individuals who will review the data. The plan might include establishing a data and safety 
monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the 
sponsor. 
 
Not applicable 
 


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9.6 
Frequency of review of cumulative data 
Describe the frequency or periodicity of review of cumulative data. 
 
Not applicable 
 
9.7 
Statistical tests 
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring. 
 
Not applicable 
 
9.8 
Suspension of research 
Describe any conditions that trigger an immediate suspension of research. 
 
Not applicable 
 
10.0 Risks 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the 
subjects’ participation in the research. Include as may be useful for the IRB’s consideration, a description of the 
probability, magnitude, duration and reversibility of the risks. Consider all types of risk including physical, 
psychological, social, legal, and economic risks.  Note: Loss of confidentiality is a potential risk when conducting 
human subject research. 
• 
If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. 
• 
If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or 
become pregnant. 
• 
If applicable, describe risks to others who are not subjects. 
 
Gastrointestinal symptoms:  
Some participants may experience GI (stomach) upset from the changes to their diet with incorporation of the 
pecans; symptoms may include, but are not limited to, any of the following: constipation/diarrhea, nausea, and 
bloating. This will likely subside once the participant becomes accustomed to the study food.  
  
Food Allergies:  
Individuals will be asked to report any food allergies during the telephone screen, however it is possible that an  
unknown food allergy may manifest during the study. This is most likely to occur within the first week of the 
treatment period. Each day participants will be asked to complete a daily monitoring form so that we may track 
any adverse events, including potential food allergies, and identify the source as soon as possible. In addition, 
we ask participants to please inform study staff immediately should any adverse events occur.  
 
Food Preparation 
Pecans and meals (i.e., chicken, steamed broccoli, and roasted potatoes OR black bean quesadilla and steamed 
broccoli) are prepared by a chef with decades of experience who adheres to food safety protocols. There is a 
possibility of foodborne illness or cross contamination, but risks will be minimized by proper food handling, 
handwashing, and cleaning procedures. Participants are instructed to refrigerate meals immediately after 
leaving the clinic. If participants do not comply, this could result in foodborne illness. However, it is possible that 
incorrect food handling during shipping, storage or preparation, if not detected, could result in food-borne 
illness. Every 


Page 25 of 45 (IRB USE ONLY: V. 03/01/2021)  
effort will be made to safeguard against this possibility. 
  
Blood Sampling:  
Blood draws often cause mild pain, swelling or bleeding. There may be some bruising (blood under the surface 
of the skin), which can be minimized by pressing on the site after the needle is removed. There is also a slight 
chance of infection, dizziness or fainting. These risks will be minimized and most likely eliminated by having 
trained staff draw the blood in a clinical setting using sterile supplies. If dizziness or fainting occurs, 
the symptoms will be alleviated by having the participant lie flat with their feet raised. If these should occur, the 
participant may be asked to remain at the clinic until the nurses have checked the participant’s blood 
pressure and are sure the participant is ok to leave.  
  
FMD: 
There are no known risks associated with ultrasound. However, because the blood pressure cuff on the 
participants’ right forearm is inflated tightly, it is likely that the hand and arm below the blood pressure cuff will 
experience “pins and needles” (tingling and pricking sensations) while the cuff is inflated and for a few minutes 
after it is released. During the 5 minutes that the blood pressure cuff is inflated on the forearm, the arm could 
become numb. This might be moderately painful. However, any discomfort or numbness should go away within 
minutes of cuff deflation and there are no known long-term risks associated with this test. There is a possibility 
for red blotching or mild bruising (petechiae) appearing on the skin above and below the location of the blood 
pressure cuff. Studies indicate that petechiae are rare (occurring in less than ½ of 1% of patients) and it is 
typically not uncomfortable and it does not require treatment. There are no risks associated with measurement 
of blood pressure, heart rate, or EKG as long as the participant is not allergic to adhesive tape. Temporary 
redness at the site of the electrode placement is possible. 
 
SphygmoCor (Pulse Wave Analysis and Pulse Wave Velocity):  
There are no known risks associated with these measurements. The sensation of pressure from the 
blood pressure cuff or hand-held probe may be uncomfortable. There is a possibility for red blotching or mild 
bruising (petechiae) appearing on the skin above and below the location of the blood pressure cuff. Studies 
indicate that petechiae are rare (occurring in less than ½ of 1% of patients) and it is typically not uncomfortable 
and does not require treatment.  
  
Loss of Confidentiality:  
There is always a potential for loss of confidentiality despite our best efforts. To prevent this from occurring 
all records are coded with a unique ID number and no names are used. Records containing names or 
other identifying information are kept under lock at the PI’s research office. All records associated with an 
individual’s participation in the study will be subject to the usual confidentiality standards applicable to medical 
records. In the event of publication of this research, no personal identifying information will be disclosed.  
  
Fecal Sample Collection:  
Some participants may experience a certain level of embarrassment or discomfort from being asked to 
collect stool samples.  
 
  
 
11.0 Potential Benefits to Subjects and Others  
11.1 
Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience from taking part in the research. 
If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. 
Compensation should be addressed in section 13.0. 
 


Page 26 of 45 (IRB USE ONLY: V. 03/01/2021)  
Participants will receive their screening laboratory results, including a complete blood count, HbA1C and 
blood lipid values, at no cost. 
11.2 
Potential Benefits to Others 
Include benefits to society or others.  
 
The findings of this study will be applicable to the approximately, 50% of Americans are at risk for CVD 
(29). If shown to improve peripheral vascular assessments, lipid and lipoprotein profile and glycemic 
control compared to usual average American intake, this may provide evidence in favor of incorporating 
pecans. As approximately one-third of deaths are caused by cardiovascular disease and events, this 
could be helpful to those at risk. The findings of this research will be published in peer reviewed journals 
and these papers will likely be cited by clinical management guidelines and inform dietary 
recommendations. Therefore, the findings of this research are likely to inform clinical practice and 
dietary guidelines for individuals who have an elevated risk of cardiovascular disease (overweight or 
obese BMI and at least one symptom of metabolic syndrome).   
12.0 Sharing Results with Subjects 
Describe whether results (study results or individual subject results, such as results of investigational diagnostic 
tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care 
physicians) and if so, describe how information will be shared.  
 
Screening results will be provided to all potential participants (regardless of their eligibility status) within 
2 weeks of their screening appointment. All screening results will be reviewed by the Nurse Practitioner 
or Physician at the Clinical Center. Should any abnormal lab values be identified that warrant further 
evaluation the individual will be contacted (by the Study Coordinator) and asked to schedule a visit with 
their primary care physician. At the completion of the study, the key findings from the study overall will 
be posted on our laboratory’s website (https://hhd.psu.edu/nutrition/cardiometabolic-lab). Upon 
request, individual results may be given to participants at the completion of all study related data 
collection and analyses.   
13.0 Subject Payment and/or Travel Reimbursements 
Describe the amount, type (cash, check, gift card, other) and timing of any subject payment or travel 
reimbursement. If there is no subject payment or travel reimbursement, indicate as not applicable.  
 
Extra or Course Credit:  Describe the amount of credit and the available alternatives. Alternatives should be 
equal in time and effort to the amount of course or extra credit offered. It is not acceptable to indicate that the 
amount of credit is to be determined or at the discretion of the instructor of the course.  
 
Approved Subject Pool: Indicate which approved subject pool will be used; include in response below that 
course credit will be given and alternatives will be offered as per the approved subject pool procedures.  
 
For their time and participation in the study participants will receive monetary compensation of up to $200 
(check or direct deposit). For participants who withdraw from the study, compensation will be prorated as 
follows and paid at the completion of their participation in the study: 
 
Completion of day 1 and day 2 testing at baseline = $50 
Completion of three 24-hour recalls at baseline= $25 
Completion of three 24-hour recalls at week 6 = $25 
Completion of day 1 and day 2 testing at 12 weeks  = $75 
Completion of three 24-hour recalls at week 12 = $25 
 


Page 27 of 45 (IRB USE ONLY: V. 03/01/2021)  
Payments will be made at the completion of a participant’s involvement with the study.  
 
Participants may not be eligible for compensation if determined that specific work or visa laws conflict. 
 
14.0 Economic Burden to Subjects 
14.1 
Costs 
Describe any costs that subjects may be responsible for because of participation in the research. 
 
The participants will not bear any costs due to their participation in the study.  
 
14.2 
Compensation for research-related injury 
If the research involves more than Minimal Risk to subjects, describe the available compensation in 
the event of research related injury. 
 
If there is no sponsor agreement that addresses compensation for medical care for research subjects 
with a research-related injury, include the following text as written - DO NOT ALTER OR DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers.  
 
For sponsored research studies with a research agreement with the sponsor that addresses 
compensation for medical care for research-related injuries, include the following text as written - DO 
NOT ALTER OR DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Such charges may be paid by the study sponsor as 
outlined in the research agreement and explained in the consent form. 
 
Not applicable – the research does not involve more than minimal risk. 
15.0 Resources Available  
 
15.1 
Facilities and locations 
Identify and describe the facilities, sites and locations where recruitment and study procedures will be 
performed.  
 
If research will be conducted outside the United States, describe site-specific regulations or customs 
affecting the research, and describe the process for obtaining local ethical review. Also, describe the 
principal investigator’s experience conducting research at these locations and familiarity with local 
culture. 
 
Penn State University Clinical Research Center -The clinical aspects of this study will be conducted at the  
Clinical Research Centre (CRC) on the University Park campus of the Pennsylvania State University. The  
CRC is a purpose-built research unit that supports human clinical research trials, and is fully equipped 
with exam rooms, invasive and general procedure rooms and five hospital-style bedrooms with 
bathrooms. There is also a specimen processing room with refrigerated and unrefrigerated centrifuges 
for preparation of samples. The study investigators will work closely with experienced CRC staff 
(physicians, nurse practitioners, registered nurses and research technologists) to optimize and facilitate 


Page 28 of 45 (IRB USE ONLY: V. 03/01/2021)  
the research protocol. The principal investigators, co-investigator, and project coordinators are 
experienced with conducting research at this location and have conducted multiple clinical trials at this 
location previously.  
 
The Penn State Metabolic Diet Study Center is a state-of-the-art facility consisting of a spacious dining 
area, a pantry and a fully-equipped kitchen specifically designed for nutrition studies. In addition, this 
area is available for small group meetings with study participants and counseling/information exchange 
with small groups of individuals. 
15.2 
Feasibility of recruiting the required number of subjects 
Indicate the number of potential subjects to which the study team has access.  Indicate the percentage 
of those potential subjects needed for recruitment. 
 
Given the wide age range and broad recruitment criteria we believe these methods, which have 
been successful in the past, will enable us to recruit the necessary participants within the appropriate 
time frame.  
15.3 
PI Time devoted to conducting the research 
Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and 
completing the research. Please consider outside responsibilities as well as other on-going research for 
which the PI is responsible. 
 
The Principal Investigators will be responsible for assuring through personal contact between the co-
investigator, clinical staff and coordinators that each individual clearly understands and accepts the 
obligations incurred in the undertaking of this clinical trial.  
 
The Principal Investigators will ensure that the clinical staff fully understand the nature of the protocol 
and the requirements for an adequate and well-controlled study; the obligation to conduct the clinical 
investigation in accordance with the applicable federal regulations; the obligation to obtain informed 
consent in accordance with 21 CFR Part 50; the obligation to obtain IRB review and approval of a clinical 
investigation before the investigation may be initiated and to ensure continuing review of the study by 
the IRB in accordance with 21 CFR Part 56. 
15.4 
Availability of medical or psychological resources 
Describe the availability of medical or psychological resources that subjects might need as a result of 
their participation in the study, if applicable. 
 
Nursing staff are always present during clinical testing. Highly trained nursing staff will perform clinical 
assessments. Should an individual require psychological services they will be referred to the on-campus 
clinic: Psychological Clinic, 314 Moore Bldg., University Park, Phone: 865-2191. 
15.5 
Process for informing Study Team 
Describe the training plans to ensure members of the research team are informed about the protocol 
and their duties, if applicable. 
 
All study staff will be required to complete the Human Participant Training and Bloodborne Pathogen  
Training as mandated by the Pennsylvania State University Office of Research Protections. In addition, as 
part of the initial training for this study, all staff members (e.g. project managers, research coordinators, 
assistants, and Clinical Research Center [CRC] nursing staff) will conduct an initial project start-up 
meeting to review the scientific protocol and ensure all study procedures are in place. 


Page 29 of 45 (IRB USE ONLY: V. 03/01/2021)  
16.0 Other Approvals 
16.1 
Other Approvals from External Entities 
Describe any approvals that will be obtained prior to commencing the research (e.g., from engaged 
cooperating institutions IRBs who are also reviewing the research and other required review 
committees, community leaders, schools, research locations where research is to be conducted by the 
Penn State investigator, funding agencies, etc.). 
 
IBC approval will be obtained for the collection and analysis of blood and fecal samples. 
16.2 
Internal PSU Committee Approvals 
 
Check all that apply: 
  Anatomic Pathology – Penn State Health only – Research involves the collection of tissues or use of 
pathologic specimens. Upload a copy of “HRP-902 - Human Tissue For Research Form” in CATS IRB.  
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy). 
 
  Clinical Laboratories – Penn State Health only – Collection, processing and/or storage of extra tubes 
of body fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids 
that had been collected for clinical purposes but are no longer needed for clinical use. Upload a copy 
of “HRP-901 - Human Body Fluids for Research Form” in CATS IRB.  
 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way. 
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 
  Radiation Safety – Penn State Health only – Research involves research-related radiation 
procedures. All research involving radiation procedures (standard of care and/or research-related) 
must upload a copy of “HRP-903 - Radiation Review Form” in CATS IRB.  
 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Penn State Health only – All investigator-written research studies requiring 
review by the convened IRB must provide documentation of scientific review with the IRB 
submission. The scientific review requirement may be fulfilled by one of the following: (1) external 
peer-review process; (2) department/institute scientific review committee; or (3) scientific review by 
the Clinical Research Center Advisory committee.  NOTE: Review by the Penn State Health Cancer 
Institute (PSCI) Protocol Review Committee or the PSCI Disease Team is required if the study 
involves cancer prevention studies or cancer patients, records and/or tissues. For more information 
about this requirement see the IRB website. 
 


Page 30 of 45 (IRB USE ONLY: V. 03/01/2021)  
  St. Joseph Administrative Review – Penn State Health only – Penn State Health Research that will be 
conducted at St. Joseph Medical Center or St. Joseph Community Medical Groups.  
 
17.0 Multi-Site Study 
If this is a multi-site study (i.e., a study in which two or more institutions coordinate, with each institution 
completing all research activities outlined in a specific protocol) and the Penn State PI is the lead investigator, 
describe the processes to ensure communication among sites in the sections below. 
[Do not type here] 
 
17.1 
Other sites  
List the name and location of all other participating sites. Provide the name, qualifications and contact 
information for the principal investigator at each site and indicate which IRB will be reviewing the study 
at each site. 
 
 
 
 
Not applicable 
 
 
17.2 
Communication Plans 
Describe the plan for regular communication between the overall study director and the other sites to 
ensure that all sites have the most current version of the protocol, consent document, etc.  Describe the 
process to ensure all modifications have been communicated to sites. Describe the process to ensure 
that all required approvals have been obtained at each site (including approval by the site’s IRB of 
record).   Describe the process for communication of problems with the research, interim results and 
closure of the study. 
 
Not applicable 
 
17.3 
Data Submission and Security Plan 
Describe the process and schedule for data submission and provide the data security plan for data 
collected from other sites.  Describe the process to ensure all engaged participating sites will safeguard 
data as required by local information security policies. 
 
Not applicable 
 
17.4 
Subject Enrollment 
Describe the procedures for coordination of subject enrollment and randomization for the overall 
project. 
 
Not applicable 
 
17.5 
Reporting of Adverse Events and New Information 
Describe how adverse events and other information will be reported from the clinical sites to the overall 
study director. Provide the timeframe for this reporting. 
 
Not applicable 
 
17.6 
Audit and Monitoring Plans 
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any 
on-site auditing and monitoring plans for the study. 
 


Page 31 of 45 (IRB USE ONLY: V. 03/01/2021)  
Not applicable 
 
18.0 Adverse Event Reporting 
18.1 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) experienced 
by a subject or other individual, which in the opinion of the investigator is determined to be (1) 
unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
19.0 Study Monitoring, Auditing and Inspecting 
 
19.1 
Auditing and Inspecting 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities (e.g., 
pharmacy, diagnostic laboratory, etc.). 
 
20.0 Future Undetermined Research: Data and Specimen Banking 
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined 
research, please describe this process in the sections below.  This information should not conflict with 
information provided in section 22 regarding whether or not data and/or specimens will be associated with 
identifiers (directly or indirectly).  If NOT applicable, indicate as such below in all sections. 
[Do not type here] 
 
20.1 
Data and/or specimens being stored 
Identify what data and/or specimens will be stored and the data associated with each specimen. 
 
Blood (serum/plasma) may be stored for future testing.  
 
Fecal samples will be stored for future testing of microbial composition or identification of metabolites. 
 
20.2 
Location of storage 
Identify the location where the data and/or specimens will be stored. 
 
Chandlee Lab: Room 318 in a locked -80o degree freezer 
 
20.3 
Duration of storage 
Identify how long the data and/or specimens will be stored. If data and/or specimens will be stored 
indefinitely, indicate as such.  


Page 32 of 45 (IRB USE ONLY: V. 03/01/2021)  
 
Specimens will be destroyed 3 years after publication of results, unless permission has been granted to 
keep. If permission to keep the samples has been granted, the samples may be stored indefinitely or 
until the integrity of the sample is comprised; these samples will be stored with non-identifiable labels. 
 
20.4 
Access to data and/or specimens 
Identify who will have access to the data and/or specimens. 
 
Specimens will be boxed, labeled by sample type, study name, and subject ID, and stored in a locked       
-80o degree freezer. Samples will only be accessible to designated staff and students for purposes 
outlined in this proposal. 
 
20.5 
Procedures to release data or specimens 
Describe the procedures to release the data and/or specimens, including: the process to request a 
release, approvals required for release, who can obtain data and/or specimens, and the data to be 
provided with the specimens. 
 
All specimens will be coded with non-identifiable labels. Participants may elect to make their samples 
available for additional analyses by study collaborators. 
 
20.6 
Process for returning results 
Describe the process for returning results about the use of the data and/or specimens. 
 
No results about the use of data or specimens are returned to participants. The samples are labeled with 
non-identifiable labels and after the list linking identifiers to the codes has been destroyed it will not be 
possible to identify individuals. 
 
21.0 References 
List relevant references in the literature which highlight methods, controversies, and study outcomes. 
 
References: 
1. 
U.S. Department of Agriculture, Agricultural Research Service. 2016. Nutrient Intakes from Food and 
Beverages: Mean Amounts Consumed per Individual, by Gender and Age, What We Eat in 
America, NHANES 2013-2014. 
2. 
Bowman SA CJ, Friday JE, Lynch KL, LaComb RP, Moshfegh AJ. Food Patterns Equivalents Intakes by 
Americans: What We Eat in America, NHANES 2003-04 and 2013-14 Dietary Data Brief No. 17. 2017. 
3. 
Dietary Guidelines Advisory Committee. Scientific report of the 2015 dietary guidelines advisory 
committee. Washington (DC): USDA and US Department of Health and Human Services 2015. 
4. 
U.S. Department of Health and Human Services. 2015-2020 Dietary Guidelines for Americans. Office of 
Disease Prevention and Health Promotion, 2016. 
5. 
Rebholz CM, Appel LJ. Health effects of dietary patterns: critically important but vastly understudied. Am 
J Clin Nutr 2018;108:207-208. 
6. 
Ros E. Nuts and CVD. Br J Nutr 2015;113 Suppl 2:S111-20. 
7. 
Gu L, Kelm MA, Hammerstone JF, Beecher G, Holden J, Haytowitz D, Gebhardt S, Prior RL. 
Concentrations of Proanthocyanidins in Common Foods and Estimations of Normal Consumption. The Journal of 
Nutrition 2004;134:613-617. 
8. 
Hooper L, Kay C, Abdelhamid A, Kroon PA, Cohn JS, Rimm EB, Cassidy A. Effects of chocolate, cocoa, and 
flavan-3-ols on cardiovascular health: a systematic review and meta-analysis of randomized trials. The American 
Journal of Clinical Nutrition 2012. 


Page 33 of 45 (IRB USE ONLY: V. 03/01/2021)  
9. 
Matsuzawa Y, Kwon TG, Lennon RJ, Lerman LO, Lerman A. Prognostic Value of Flow‐Mediated 
Vasodilation in Brachial Artery and Fingertip Artery for Cardiovascular Events: A Systematic Review and Meta‐
Analysis. Journal of the American Heart Association 2015;4. 
10. 
Balzer J, Rassaf T, Heiss C, Kleinbongard P, Lauer T, Merx M, Heussen N, Gross HB, Keen CL, Schroeter H, 
Kelm M. Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic 
patients a double-masked, randomized, controlled trial. J Am Coll Cardiol 2008;51:2141-9. 
11. 
Casas-Agustench P, Lopez-Uriarte P, Ros E, Bullo M, Salas-Salvado J. Nuts, hypertension and endothelial 
function. Nutr Metab Cardiovasc Dis 2011;21 Suppl 1:S21-33. 
12. 
Neale EP, Tapsell LC, Guan V, Batterham MJ. The effect of nut consumption on markers of inflammation 
and endothelial function: a systematic review and meta-analysis of randomised controlled trials. BMJ Open 
2017;7:e016863. 
13. 
Del Gobbo LC, Falk MC, Feldman R, Lewis K, Mozaffarian D. Effects of tree nuts on blood lipids, 
apolipoproteins, and blood pressure: systematic review, meta-analysis, and dose-response of 61 controlled 
intervention trials. The American Journal of Clinical Nutrition 2015;102:1347-1356. 
14. 
Tindall A, Johnston E, Kris-Etherton P, Petersen K. The effect of nuts on markers of glycemic control: a 
systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr 2019;109:297–314. 
15. 
Viguiliouk E, Kendall CW, Blanco Mejia S, Cozma AI, Ha V, Mirrahimi A, Jayalath VH, Augustin LS, 
Chiavaroli L, Leiter LA, de Souza RJ, Jenkins DJ, Sievenpiper JL. Effect of tree nuts on glycemic control in diabetes: 
a systematic review and meta-analysis of randomized controlled dietary trials. PLoS ONE 2014;9:e103376. 
16. 
Morgan WA, Clayshulte BJ. Pecans lower low density lipoprotein cholesterol in people with normal lipid 
levels. Journal of the American Dietetic Association 2000;100:312-318. 
17. 
Rajaram S, Burke K, Connell B, Myint T, Sabaté J. A monounsaturated fatty acid–rich pecan-enriched diet 
favorably alters the serum lipid profile of healthy men and women. The Journal of Nutrition 2001;131:2275-
2279. 
18. 
McKay DL, Eliasziw M, Chen CYO, Blumberg JB. A Pecan-Rich Diet Improves Cardiometabolic Risk Factors 
in Overweight and Obese Adults: A Randomized Controlled Trial. Nutrients 2018;10. 
19. 
Hudthagosol C, Haddad EH, McCarthy K, Wang P, Oda K, Sabate J. Pecans acutely increase plasma 
postprandial antioxidant capacity and catechins and decrease LDL oxidation in humans. J Nutr 2011;141. 
20. 
Wang L, Bordi PL, Fleming JA, Hill AM, Kris‐Etherton PM. Effect of a Moderate Fat Diet With and Without 
Avocados on Lipoprotein Particle Number, Size and Subclasses in Overweight and Obese Adults: A Randomized, 
Controlled Trial. Journal of the American Heart Association 2015;4:e001355. 
21. 
Tindall AM, Petersen KS, Skulas-Ray AC, Richter CK, Proctor DN, Kris-Etherton PM. Replacing Saturated 
Fat With Walnuts or Vegetable Oils Improves Central Blood Pressure and Serum Lipids in Adults at Risk for 
Cardiovascular Disease: A Randomized Controlled-Feeding Trial. J Am Heart Assoc 2019;8:e011512. 
22. 
Lassale C, Tzoulaki I, Moons KGM, Sweeting M, Boer J, Johnson L, Huerta JM, Agnoli C, Freisling H, 
Weiderpass E, Wennberg P, van der A DL, Arriola L, Benetou V, Boeing H, Bonnet F, Colorado-Yohar SM, 
Engström G, Eriksen AK, Ferrari P, Grioni S, Johansson M, Kaaks R, Katsoulis M, Katzke V, Key TJ, Matullo G, 
Melander O, Molina-Portillo E, Moreno-Iribas C, Norberg M, Overvad K, Panico S, Quirós JR, Saieva C, Skeie G, 
Steffen A, Stepien M, Tjønneland A, Trichopoulou A, Tumino R, van der Schouw YT, Verschuren WMM, 
Langenberg C, Di Angelantonio E, Riboli E, Wareham NJ, Danesh J, Butterworth AS. Separate and combined 
associations of obesity and metabolic health with coronary heart disease: a pan-European case-cohort analysis. 
European Heart Journal 2017:ehx448-ehx448. 
23. 
Kollias A, Lagou S, Zeniodi ME, Boubouchairopoulou N, Stergiou GS. Association of Central Versus 
Brachial Blood Pressure With Target-Organ Damage: Systematic Review and Meta-Analysis. Hypertension 
2016;67:183-90. 
24. 
Ben-Shlomo Y, Spears M, Boustred C, May M, Anderson SG, Benjamin EJ, Boutouyrie P, Cameron J, Chen 
CH, Cruickshank JK, Hwang SJ, Lakatta EG, Laurent S, Maldonado J, Mitchell GF, Najjar SS, Newman AB, Ohishi M, 
Pannier B, Pereira T, Vasan RS, Shokawa T, Sutton-Tyrell K, Verbeke F, Wang KL, Webb DJ, Hansen TW, Zoungas 
S, McEniery CM, Cockcroft JR, Wilkinson IB. Aortic pulse wave velocity improves cardiovascular event prediction: 
an individual participant meta-analysis of prospective observational data from 17,635 subjects. J Am Coll Cardiol 
2014;63:636-46. 


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25. 
Ma Y, Njike VY, Millet J, Dutta S, Doughty K, Treu JA, Katz DL. Effects of walnut consumption on 
endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial. Diabetes Care 
2010;33:227-232. 
26. 
Ros E, Nunez I, Perez-Heras A, Serra M, Gilabert R, Casals E, Deulofeu R. A walnut diet improves 
endothelial function in hypercholesterolemic subjects: a randomized crossover trial. Circulation 2004;109. 
27. 
Sari I, Baltaci Y, Bagci C, Davutoglu V, Erel O, Celik H, Ozer O, Aksoy N, Aksoy M. Effect of pistachio diet 
on lipid parameters, endothelial function, inflammation, and oxidative status: a prospective study. Nutrition 
2010;26:399-404. 
28. 
Chen C-YO, Holbrook M, Duess M-A, Dohadwala MM, Hamburg NM, Asztalos BF, Milbury PE, Blumberg 
JB, Vita JA. Effect of almond consumption on vascular function in patients with coronary artery disease: a 
randomized, controlled, cross-over trial. Nutrition Journal 2015;14:1-11. 
29. 
Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang 
AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, 
Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, 
Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson 
UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, 
VanWagner LB, Wilkins JT, Wong SS, Virani SS. Heart Disease and Stroke Statistics-2019 Update: A Report From 
the American Heart Association. Circulation 2019;139:e56-e66. 
  
 
 
22.0 Confidentiality, Privacy and Data Management  
IMPORTANT: The following section is required for all locations EXCEPT Penn State Health and the College of 
Medicine.  Penn State Health and College of Medicine should skip this section and complete “HRP-598 
Research Data Plan Review Form.” In order to avoid redundancy, for this section state “See the Research Data 
Plan Review Form” if you are conducting Penn State Health research. Delete all other sub-sections of section 
22. 
 
For research being conducted at Penn State Health or by Penn State Health researchers only: The research 
data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form.”   
 
Refer to Penn State College of Medicine IRB’s “Standard Operating Procedure Addendum: Security and 
Integrity of Human Research Data,” which is available on the IRB’s website. In order to avoid redundancy, for 
this section state “See the Research Data Plan Review Form” if you are conducting Penn State Health 
research. Delete all sub-sections of section 22.  
 
For all other research: complete the following section.  Please refer to PSU Policy AD95 for information 
regarding information classification and security standards and requirements.  It is recommended that you work 
with local IT staff when planning to store, process, or access data electronically to ensure that your plan can be 
carried out locally and meets applicable requirements.   If you have questions about Penn State’s Policy AD95 or 
standards or need a consultation regarding data security, please contact security@psu.edu.  
 
22.1 Which of the following identifiers will be recorded for the research project? Check all that apply. If none of 
the following identifiers will be recorded, do not check any of the boxes. 
 
 
Hard 
Copy 
Data 
Electronic  
Stored  
Data  
Names and/or initials (including on signed consent documents) 
 
  


Page 35 of 45 (IRB USE ONLY: V. 03/01/2021)  
All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip 
code, and their equivalent geocodes, 
 
  
All elements of dates (except year) for dates directly related to an individual, including birth date, 
admission date, discharge date, date of death; and all ages over 89 and all elements of dates 
(including year) indicative of such age, except that such ages and elements may be aggregated into 
a single category of age 90 or older 
 
  
Telephone numbers 
 
  
Fax numbers 
 
  
Electronic mail addresses 
 
  
Social security numbers 
 
  
Medical record numbers 
 
  
Health plan beneficiary numbers 
 
  
Account numbers 
 
  
Certificate/license numbers 
 
  
Vehicle identifiers and serial numbers, including license plate numbers 
 
  
Device identifiers and serial numbers 
 
  
Web Universal Resource Locators (URLs) 
 
  
Internet Protocol (IP) address numbers 
 
  
Biometric identifiers, including finger and voice prints 
 
  
Full face photographic images and any comparable images 
 
  
Any other unique identifying number, characteristic, or code (such as the pathology number) 
 
  
Study code number with linking list 
 
  
Genomic sequence data 
 
 
State ID numbers 
 
 
Passport numbers 
 
 
Driver’s license numbers 
 
 
 
22.2 
If storing paper records of research data, answer the following questions: 
22.2.1 Where will the paper records, including copies of signed consent forms, associated with this 
research study will be stored? 
Consent forms and data collections sheets will be stored in a locked filing cabinet in a locked office (317 
Chandlee Laboratory) and in the Clinical Research Centre, Noll Laboratory. Medical history forms will only 
be stored in paper form in locked filling cabinets in 317 Chandlee Laboratory and in the Clinical Research 
Centre, Noll Laboratory.  
 
 
 
 
 
 
 
  
22.2.2 How will the paper records be secured?  
 
 
 
Paper recorded will be secured in a locked filing cabinet in a locked office. Only research  
 
 
 
personnel have access to the filing cabinet.   
22.2.3 How will access to the paper records be restricted to authorized project personnel? 
 
 
Only authorized project personnel will have key access to the locked filing cabinets.  
 
22.3 
If storing electronic records of research data, indicate where the electronic data associated with this 
research study will be stored. Check all that apply.         
 
 Penn State-provided database application.  Check which of the following database applications 
are being used (check all that apply): 
  Penn State REDCap   
  Other – Specify - provided and approved database application:  


Page 36 of 45 (IRB USE ONLY: V. 03/01/2021)  
OneDrive 
       
 
  Penn State, College, or Department IT file server  
 
        
 
  Box.psu.edu (To be retired Sept. 2021; see https://storage.psu.edu/)       
  Web-based system provided by the sponsor or cooperative group - Specify URL and contact 
information:  
      
        
 
  Other – Specify the database application or server: 
      
Provide details about the data security features or attach security documentation provided 
by sponsor or group: 
      
 
If there is a list/key that links indirect identifiers (code numbers, participant IDs, etc.) to direct identifiers, that list 
must not be comingled (i.e., stored in the same location) as the identifiable data, including copies of signed 
informed consent forms. Additionally, access to that list/key must be restricted to authorized project personnel. 
 
22.4 
Is there a list/key that links code numbers to identifiers?  
  Yes - explain how the list that links the code to identifiers is stored separately from coded data: 
A master list containing a study ID number and participant’s identity will be used. This file will be stored 
in a folder saved to OneDrive where only approved study personnel will be able to access it through their 
OneDrive account. No data containing study ID#'s (code numbers) will be stored with the master list.  
Upon completion of data collection, only the investigators and study coordinator will have access to the 
list. This list will be deleted 3 years after publication of the study results. 
 Not applicable, there is no list that links code numbers to identifiers. Skip to section 22.6. 
 
22.5 
Is there a list of people who have access to the list/key? 
 
  Yes – explain how access to that list is restricted and why certain persons require access. 
The principal investigator, co-investigator, study coordinators and trained study personnel will 
have access to data and specimens. These personnel will have access to the list because they 
will be directly involved with the study participants and therefore need access to identifying 
information in the course of participant management.    
 
 
  No – explain why not: 
 
      
 
22.6 
Describe the mechanism in place to ensure only approved research personnel have access to the 
stored research data (electronic and paper). 
  Password-protected files 
  Role-based security  
  Specify all other mechanisms used to ensure only permitted users have access to the stored 
research data. 
 
 
Paper files are stored under lock and key.  
The use of mobile devices or wireless activity trackers to collect identifiable research data must be approved by the 
Office of Information Security. Before completing this section, please contact security@psu.edu to confirm approval. 
 


Page 37 of 45 (IRB USE ONLY: V. 03/01/2021)  
22.7 
Will any research data (such as survey data) be collected on a mobile device, such as an electronic 
tablet, cell phone, or wireless activity tracker?  
 No 
 Yes - answer the following questions: 
22.7.1 Specify the provider of the mobile devices(s) 
 Supplied by the sponsor 
 Penn State owned device 
 A personal device 
 Other – Please specify source:       
 
22.7.2 Specify the type(s) of mobile device(s) that will be used to capture data and all identifiers 
captured on the mobile device(s). Please list all devices, and if more than one, the identifiers 
to be collected on each. 
      
22.7.3 Specify the type of data collected on the mobile devices(s).  
      
 
22.7.4 Specify the application or website used to collect the data from the mobile device, if 
applicable. 
      
 
22.7.5 Describe the measures taken to protect the confidentiality of the data collected on mobile 
device(s). Please address physical security of the device(s), electronic security, and secure 
transfer of data from device(s) to the previously indicated data/file storage location provided 
in section 22.3. 
      
The use of online survey tools and email to collect or send research data containing identifiers that represent more 
than minimal risk to subjects must be approved by the Office of Information Security. Before completing this section, 
please contact security@psu.edu. 
 
22.8 
Will any research data be directly entered/sent by subjects over the internet or via email (e.g., data 
capture using on-line surveys/questionnaires, surveys via email, observation of chat rooms or blogs)? 
 No 
 Yes - answer the following questions: 
22.8.1 Specify the identifiers collected over the internet or via email (Including IP addresses if IP 
addresses will be collected). 
The ASA24 system does not collect any identifying data directly from Respondents. However, IP 
address information is accessed for the purpose of routing information between the server and the 
respondent's computer—often the IP address is that of the user's Internet Service Provider (ISP). IP 
addresses are not stored or tracked by the ASA24 system. However, logs of connections are kept in the 
hosting environment for audit trail purposes. This information is not mined in any way but would be 
available if there were a legal obligation to release it. 


Page 38 of 45 (IRB USE ONLY: V. 03/01/2021)  
22.8.2 Specify the type of data collected over the internet or via email. 
      Intake of foods, beverages and supplements in the past 24 hours. All subjects are provided 
with a unique personal link that aligns with their study ID for completion of the survey so no identifying 
information is collected. 
22.8.3 Describe the measures taken to protect the confidentiality of the data collected? 
      All subjects are provided will a unique personal link that aligns with their study ID that they 
use to access the survey. No identifying information is uploaded to the website or collected from the 
subject. 
22.8.4 Describe how the research team will access the data once data collection is complete. 
      Response data are secured at the hosting site using industry standard security controls, 
including firewalls and encryption. All data entered into the ASA24 system at the Respondent’s computer is 
encrypted by the internet browser (e.g., Internet Explorer, Firefox) before they are transmitted to our 
servers using Secure Socket Layer (SSL) Technology. SSL allows for the authentication of the sending and 
receiving computers.   
Only approved study members and the ASA24 operations team can access response data. Access is 
gained through the Researcher Portal, which is username and strong password protected. Data are 
downloaded in spreadsheets directly from the Researcher Portal. 
22.8.5 If the research involves online surveys, list the name(s) of the service provider(s) that will be 
used for the survey(s) (e.g., REDCap, Penn State licensed Qualtrics, Survey Monkey, 
Zoomerang)? (Note: The IRB strongly recommends the use of REDCap for online surveys that 
obtain sensitive identifiable human subjects data.) 
 Penn State REDCap 
 Penn State Qualtrics (de-identified data only) 
 Other - Please specify: 
Application: National Cancer Institute ASA-24 
URL (If applicable): https://epi.grants.cancer.gov/asa24/  
22.8.6 If the answer above is “Other” contact security@psu.edu for approval of an alternative data 
capture method 
      
 
Depending on the nature of the subject matter involved, certain security requirements must be in place for the audio 
and/or video recording or photographing of subjects. If the subject matter presents more than minimal risk to the 
subjects, then, before completing the section below, please contact the Office of Information Security at 
security@psu.edu to confirm whether these requirements are required. 
22.9 
Will any type of recordings (e.g., audio or video) or photographs of the subjects be made during this 
study? 
 No - skip to section 22.10 
 Yes - answer the following questions: 
22.9.1 What will be used to capture the audio/video/images? Give a brief description of content. 
 Audio – Describe the intended content of the audio recording: 
      
 Video – Describe the intended content of the video recording: 


Page 39 of 45 (IRB USE ONLY: V. 03/01/2021)  
      
 Photographs of the subjects – Describe the intended content of the  photographs: 
      
 3-D Images – Describe the intended content of the of 3-D images: 
       
 Other - Specify:  
      
22.9.2 How will the recordings/photographs/images be stored (electronically or physically)? 
 
22.9.3 Where will the recordings/photographs/images be stored? 
      
22.9.4 Who will have access to the recordings/photographs/images? 
      
22.9.5 Will any of the recordings be transcribed? 
 Not applicable 
 No 
 Yes – indicate who will be doing the transcribing?  
      
22.9.6 Will the recordings/photographs be used for purposes other than this research study? 
 No 
 Yes - specify purpose(s) (e.g., publication, presentations, educational training, future 
 undetermined research): 
      
22.10 Certificate of Confidentiality (COC) - Is the research biomedical, behavioral, clinical or other research 
that is funded by the National Institutes of Health (NIH)? 
 Yes - check one of the following:  
  The research involves human subjects as defined by the DHHS regulations (See Worksheet  
HRP-310). 
  The research involves collecting or using biospecimens that are identifiable to an individual. 
  If collecting or using biospecimens as part of the research, there is a small risk that some 
combination of the biospecimen, a request for the biospecimen, and other available data 
sources could be used to deduce the identity of an individual. 
  The research involves the generation of individual level, human genomic data. 
 
Note:  If any of the 4 items above are checked, a COC is automatically issued by NIH and 
applies to the research. Information about the COC must be included in the consent form. 
 No - answer the following question. 
If the research is not funded by NIH, will the investigator apply for a COC for this research study?  
 No 
 Yes 
 
Note:  For research not funded by NIH, the IRB may require a COC if the research is collecting 
personally identifiable information and the information is sensitive and/or the research is 
collecting information that if disclosed could significantly harm or damage the subject.  


Page 40 of 45 (IRB USE ONLY: V. 03/01/2021)  
 
22.11 What steps will be taken to protect subjects’ privacy interests? (Check all that apply.) 
  Identification and recruitment of potential subjects follows procedures consistent with privacy 
standards 
  Consent discussion and research interventions will take place in a private setting 
  Limiting the information being collected to only the minimum amount of data necessary to 
accomplish the research purposes  
  Limiting the people with access to the identifiable research data to the minimum necessary as 
specified in the application and consent process 
  Other – Specify:  
      
 
22.12 What is the process for ensuring correctness of data entry? 
  Double data entry to reduce risk of errors 
  Electronic edit checks to ensure data being entered are not obviously incorrect 
  Random internal quality and assurance checking of research data 
  Direct entry by subjects 
  Other - Specify:  
      
 
22.13 Does this research involve the generation of large-scale human genomic data as defined in NIH 
Genomic Data Sharing Policy (http://gds.nih.gov)? 
  No 
  Yes – If Yes, describe the plan for de-identifying the dataset before sharing it with NIH-designated 
data repositories.  
      
 
22.14 The European Union (EU) General Data Protection Regulation (GDPR)  
22.14.1 To determine if the research is subject to the GDPR answer the following questions: 
22.14.1.1 Will the Penn State principal investigator, or another entity under the 
Penn State principal investigator’s direction, be collecting, recording, 
storing, using, any personal data* of any subjects physically located in the 
European Economic Area (EEA)** at the time of data collection (even if the 
subject is NOT an EEA resident) or any EEA citizens? (This includes 
recruitment through social media sites, use of third party internet sites, 
mobile devices or apps to collect data, and/or direct receipt of data from 
subjects.) 
  No 
  Yes (This research may be subject to the GDPR) 
22.14.1.2 Does this research involve the transfer of personal data collected under 
the GDPR from an EEA country? (This includes direct transfer of data from 
research collaborators.) 
  No 
  Yes (This research may be subject to the GDPR) 
 


Page 41 of 45 (IRB USE ONLY: V. 03/01/2021)  
22.14.2 If the research may be subject to the GDPR as indicated in the answers to the questions 
above, answer the following: 
22.14.2.1 Will any of the data fall into one of the following categories: health data, 
racial or ethnic origin, political opinions, religious or philosophical beliefs, 
trade union membership, genetic data, biometric data used for purpose of 
identifying an individual, sex life or sexual orientation? 
  No 
  Yes 
22.14.2.2 Will any of the data be related to criminal convictions or offenses? 
  No 
  Yes 
Comments on any of the above responses: 
      
* “Personal data” means any information relating to an identified or identifiable natural person; an identifiable 
natural person is one who can be identified, directly or indirectly, by reference to an identifier such as a name, an 
identification number, location data, an online identifier or to one or more factors specific to the physical, 
physiological, genetic, mental, economic, cultural or social identity of that natural person. 
** European Economic Area (EEA) – Includes the 28-member states of the European Union (Austria, Belgium, 
Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, 
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, 
Slovenia Spain, Sweden, UK) and Norway, Iceland, Lichtenstein.  
22.15 Does this research involve transfer or disclosure of data and/or specimens to and/or from Penn State? 
  No - skip the remainder of section 22.15. 
  Yes - answer the following questions. 
 
Check all that apply: 
 Data are being transferred or disclosed to Penn State  
 
What is the name of the third party(ies) (the institution, sponsor, etc.) sending or providing the 
data? 
LabCorp (Morrisville, NC) 
Quest Diagnostics (Pittsburgh, PA) 
 
Is the third party requiring us to sign a contract regarding the data?  
 Yes - If Yes, this contract must go through the Office of Sponsored Programs 
https://www.research.psu.edu/osp/overview-pages/data-use-agreements 
 No 
 Data are being transferred or disclosed from Penn State  
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) receiving or accessing 
the data? 
      
 
Note: Data transfers or disclosures may require a Data Use Agreement (DUA). 
 Specimens are being transferred to Penn State  


Page 42 of 45 (IRB USE ONLY: V. 03/01/2021)  
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) sending the specimens? 
      
 
 Specimens are being transferred from Penn State  
What is the name(s) of the third party(ies) (the institution, sponsor, etc.) receiving the specimens?  
LabCorp and Quest Diagnostics 
 
Note: All material transfers, either sending or receiving, require a Material Transfer Agreement 
(MTA).  Please contact the Office of Technology Management for more information.  
22.15.1 Describe how the data/specimens will be securely transferred or disclosed to/from the third 
party(ies). 
LabCorp and Quest Diagnostics 
Serum/plasma samples will be shipped to Quest on dry ice via FedEx or a Quest Courier. The  
 
 
 
Blood samples will be labeled with the subjects study ID number and the timepoint of collection;  
 
 
 
no other information will be on the vial.    
22.15.2 How are the research data/specimens being transferred from and/or sent to the third 
party(ies)? Complete the appropriate section(s) and check all that apply within each 
completed section. 
22.15.2.1 Data being transferred or disclosed to Penn State: 
  Data are being received in aggregate/metrics (just counts, no individual 
data) 
  De-identified individual data are being received and there is no linking 
list at either institution (no identifiers, or links to identifiers, such as code 
numbers) 
 Coded research data without any identifiers are being received and the 
linking list remains with the entity sending the data; the recipient of the 
data will not have access to the linking list 
  Coded research data with identifiers (such as dates and/or any of the 
identifiers listed in section 22.15.3 aside from Study Code) are being 
received and the linking list remains with the entity sending the data; the 
recipient of the data will not have access to the linking list  
  Data with identifiers (such as dates and/or any of the identifiers listed in 
section 22.15.3) are being received and the linking list remains with the 
entity sending the data; the recipient of the data will have access to the 
linking list  
  Data with identifiers along with the linking list are being received  
  Other – Specify:  
 
 
 
 
 
Data with only the Study ID are being received by PSU. The linking list remains with the PSU; the entity 
sending the data will not have access to the linking list 
 
22.15.2.2 Data being transferred or disclosed from Penn State: 
  Data are being sent in aggregate/metrics (just counts, no individual data) 
  De-identified individual data are being sent and there is no linking list at 
either institution (no identifiers, or links to identifiers, such as code 
numbers) 


Page 43 of 45 (IRB USE ONLY: V. 03/01/2021)  
  Coded research data without any identifiers are being sent and the linking 
list remains with the entity sending the data; the recipient of the data will 
not have access to the linking list 
  Coded research data with identifiers (such as dates and/or any of the 
identifiers listed in section 22.15.3 aside from Study Code) are being sent 
and the linking list remains with the entity sending the data; the recipient 
of the data will not have access to the linking list  
  Data with identifiers (such as dates and/or any of the identifiers listed in 
section 22.15.3) are being sent and the linking list remains with the entity 
sending the data; the recipient of the data will have access to the linking 
list  
  Data with identifiers along with the linking list are being sent 
  Other – Specify:  
      
 
22.15.2.3 Specimens being transferred or disclosed to Penn State: 
  De-identified specimens are being received and there is no linking list at 
either institution (no identifiers, or links to identifiers, such as code 
numbers) 
  Coded specimens without any identifiers are being received and the 
linking list remains with the entity sending the specimens; the recipient 
of the specimens will not have access to the linking list 
  Coded specimens with identifiers (such as dates and/or any of the 
identifiers listed in section 22.15.3 aside from Study Code) are being 
received and the linking list remains with the entity sending the 
specimens; the recipient of the specimens will not have access to the 
linking list  
  Coded specimens with identifiers (such as dates and/or any of the 
identifiers listed in section 22.15.3) are being received and the linking list 
remains with the entity sending the specimens; the recipient of the 
specimens will have access to the linking list  
  Coded specimens with identifiers along with the linking list are being 
received  
  Other – Specify:  
      
 
22.15.2.4 Specimens being transferred or disclosed from Penn State: 
  De-identified specimens are being sent and there is no linking list at 
either institution (no identifiers, or links to identifiers, such as code 
numbers) 
  Coded specimens without any identifiers are being sent and the linking 
list remains with the entity sending the specimens; the recipient of the 
specimens will not have access to the linking list 
  Coded specimens with identifiers (such as dates and/or any of the 
identifiers listed in section 22.15.3 aside from Study Code) are being 
sent and the linking list remains with the entity sending the specimens; 
the recipient of the specimens will not have access to the linking list  
  Coded specimens with identifiers (such as dates and/or any of the 
identifiers listed in section 22.15.3) are being sent and the linking list 


Page 44 of 45 (IRB USE ONLY: V. 03/01/2021)  
remains with the entity sending the specimens; the recipient of the 
specimens will have access to the linking list  
  Coded specimens with identifiers along with the linking list are being 
sent  
  Other – Specify:  
      
 
 
22.15.3 If transferring data/specimens with identifiers to or from Penn State, which of the following identifiers will 
be included with the data/specimens? Check all that apply: 
 Names 
 Medical record numbers  
 Initials 
 Health plan beneficiary numbers  
 Street address  
 Account numbers  
 City 
 Certificate/license numbers 
 Driver’s License numbers 
 Passport numbers 
 State 
 State ID numbers 
 Zip Codes   
 Vehicle identifiers and serial numbers, including license plate numbers  
 County 
 Device identifiers and serial numbers  
 Geocodes 
 Web Universal Resource Locators (URLs) 
 Precincts 
 Internet Protocol (IP) address numbers 
 All elements of dates (except year) for dates 
directly related to an individual, including birth date, 
admission date, discharge date, date of death  
 Biometric identifiers, including finger and voice prints 
 Ages > 89 and all elements of dates (including 
year) indicative of such age, except that such ages 
and elements may be aggregated into a single 
category of age 90 or older  
 Full face photographic images and any comparable images  
 Telephone numbers 
 Any other unique identifying number, characteristic, or code (such as 
the pathology number) 
Specify:       
 Fax numbers 
 Study code numbers  
 Electronic mail addresses 
 Master list linking study code numbers to subject(s) 
 Social security numbers 
 Genomic sequence data 
 
 Other – specify:       
 
 
Balzer, J., Rassaf, T., Heiss, C., Kleinbongard, P., Lauer, T., Merx, M., . . . Kelm, M. (2008). Sustained benefits in vascular function 
through flavanol-containing cocoa in medicated diabetic patients a double-masked, randomized, controlled trial. J Am Coll 
Cardiol, 51(22), 2141-2149. doi:10.1016/j.jacc.2008.01.059 
Casas-Agustench, P., Lopez-Uriarte, P., Ros, E., Bullo, M., & Salas-Salvado, J. (2011). Nuts, hypertension and endothelial function. 
Nutr Metab Cardiovasc Dis, 21 Suppl 1, S21-33. doi:10.1016/j.numecd.2011.01.009 
Del Gobbo, L. C., Falk, M. C., Feldman, R., Lewis, K., & Mozaffarian, D. (2015). Effects of tree nuts on blood lipids, 
apolipoproteins, and blood pressure: systematic review, meta-analysis, and dose-response of 61 controlled intervention trials. 
The American Journal of Clinical Nutrition, 102(6), 1347-1356. doi:10.3945/ajcn.115.110965 
Gu, L., Kelm, M. A., Hammerstone, J. F., Beecher, G., Holden, J., Haytowitz, D., . . . Prior, R. L. (2004). Concentrations of 
Proanthocyanidins in Common Foods and Estimations of Normal Consumption. The Journal of Nutrition, 134(3), 613-617. 
Retrieved from http://jn.nutrition.org/content/134/3/613.abstract 
Hooper, L., Kay, C., Abdelhamid, A., Kroon, P. A., Cohn, J. S., Rimm, E. B., & Cassidy, A. (2012). Effects of chocolate, cocoa, and 
flavan-3-ols on cardiovascular health: a systematic review and meta-analysis of randomized trials. The American Journal of 
Clinical Nutrition. doi:10.3945/ajcn.111.023457 
Hudthagosol, C., Haddad, E. H., McCarthy, K., Wang, P., Oda, K., & Sabate, J. (2011). Pecans acutely increase plasma postprandial 
antioxidant capacity and catechins and decrease LDL oxidation in humans. J Nutr, 141. doi:10.3945/jn.110.121269 
Matsuzawa, Y., Kwon, T. G., Lennon, R. J., Lerman, L. O., & Lerman, A. (2015). Prognostic Value of Flow‐Mediated Vasodilation in 
Brachial Artery and Fingertip Artery for Cardiovascular Events: A Systematic Review and Meta‐Analysis. Journal of the 
American Heart Association, 4(11). doi:10.1161/jaha.115.002270 


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McKay, D. L., Eliasziw, M., Chen, C. Y. O., & Blumberg, J. B. (2018). A Pecan-Rich Diet Improves Cardiometabolic Risk Factors in 
Overweight and Obese Adults: A Randomized Controlled Trial. Nutrients, 10(3). doi:10.3390/nu10030339 
Morgan, W. A., & Clayshulte, B. J. (2000). Pecans lower low density lipoprotein cholesterol in people with normal lipid levels. 
Journal of the American Dietetic Association, 100(3), 312-318.  
Neale, E. P., Tapsell, L. C., Guan, V., & Batterham, M. J. (2017). The effect of nut consumption on markers of inflammation and 
endothelial function: a systematic review and meta-analysis of randomised controlled trials. BMJ Open, 7(11), e016863. 
doi:10.1136/bmjopen-2017-016863 
Rajaram, S., Burke, K., Connell, B., Myint, T., & Sabaté, J. (2001). A monounsaturated fatty acid–rich pecan-enriched diet favorably 
alters the serum lipid profile of healthy men and women. The Journal of Nutrition, 131(9), 2275-2279.  
Ros, E. (2015). Nuts and CVD. Br J Nutr, 113 Suppl 2, S111-120. doi:10.1017/s0007114514003924 
Tindall, A., Johnston, E., Kris-Etherton, P., & Petersen, K. (2019). The effect of nuts on markers of glycemic control: a systematic 
review and meta-analysis of randomized controlled trials. Am J Clin Nutr, 109, 297–314.  
Tindall, A. M., Petersen, K. S., Skulas-Ray, A. C., Richter, C. K., Proctor, D. N., & Kris-Etherton, P. M. (2019). Replacing Saturated 
Fat With Walnuts or Vegetable Oils Improves Central Blood Pressure and Serum Lipids in Adults at Risk for Cardiovascular 
Disease: A Randomized Controlled-Feeding Trial. J Am Heart Assoc, 8(9), e011512. doi:10.1161/jaha.118.011512 
U.S. Department of Health and Human Services. (2016). 2015-2020 Dietary Guidelines for Americans. Office of Disease Prevention 
and Health Promotion 
Viguiliouk, E., Kendall, C. W., Blanco Mejia, S., Cozma, A. I., Ha, V., Mirrahimi, A., . . . Sievenpiper, J. L. (2014). Effect of tree nuts 
on glycemic control in diabetes: a systematic review and meta-analysis of randomized controlled dietary trials. PLoS ONE, 
9(7), e103376. doi:10.1371/journal.pone.0103376 
Wang, L., Bordi, P. L., Fleming, J. A., Hill, A. M., & Kris‐Etherton, P. M. (2015). Effect of a Moderate Fat Diet With and Without 
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Trial. Journal of the American Heart Association, 4(1), e001355. doi:10.1161/jaha.114.001355 
 

ICF_006.pdf: 
Page 1 of 14 (v.4/22/2022) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cardiometabolic Effects of Pecans as a Snack 
NCT05071807 
April 22, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 2 of 14 (v.4/22/2022) 
 
 
 
 
 
CONSENT FOR RESEARCH 
The Pennsylvania State University 
 
Title of Project: Cardiometabolic effects of including pecans as a snack to improve diet quality: a 
randomized controlled study 
Principal Investigator: 
 
Name: Dr. Kristina Petersen 
Address: 303 Chandlee Lab, 
University Park 16802 
Telephone: 814-865-7206 
 
Subject’s Printed Name:   
 
 
KEY INFORMATION 
The following is a short summary of this study to help you decide whether or not to be a part of this research. 
More detailed information is listed later in this form. If you have any questions, be sure to ask the study team. 
 
Why am I being invited to take part in a research study? 
We invite you to take part in a research study because you meet our age, BMI, smoking, and medication 
requirements and are free of heart disease, stroke, kidney or liver disease. 
 
What is the purpose of this research study? 
The purpose of this voluntary research study is to study how including 2 oz./day of pecans in your diet or 
continuing your current diet affects risk factors for heart disease and diabetes. 
 
How long will the research study last? 
This study will last 12 weeks. 
Screening appointment:   
Day 1: Forms, blood pressure, weight, height, waist circumference, blood draw – 45-60 minutes  
(pregnancy testing: females only – 5 minutes)  
 
Beginning of treatment period: 
Day 1: blood draw, weight, waist circumference, vascular testing– 60 minutes   
(pregnancy testing: females only – 5 minutes)  
Consume meal that is provided for your dinner/supper meal 
 
Day 2: blood draw, FMD – 45 minutes   
We are asking you to be in a research study. This form gives you information about the research. 
Whether or not you take part is up to you. You can choose not to take part. You can agree to take part 
and later change your mind. Your decision will not be held against you. 
Please ask questions about anything that is unclear to you and take your time to make your choice. 


Page 3 of 14 (v.4/22/2022) 
 
 
 
End of treatment period (week 12):  
Day 1: blood draw, weight, waist circumference, vascular testing– 45 minutes   
(pregnancy testing: females only – 5 minutes)  
Consume meal that is provided for your dinner/supper meal 
 
Day 2: blood draw, vascular testing – 45 minutes   
 
Picking up food/gift card and compliance tracking sheet questionnaires and calls, fecal collections, and completing 
24-hour diet recalls: ~ 7 hours  
 
Total time for clinic and diet center visits from the beginning to the end of the study ~12 hours 
 
What will you need to do? 
For this study, you will be asked to attend clinic visits (blood vessel measures and blood draws), provide fecal 
samples, pick up study foods/gift cards and complete compliance tracking sheets, and complete 9 dietary records. 
 
What are the main risks of taking part in the study? 
For this study, the main risks to know about are:  
 
-Allergic reaction to pecans; cross contamination of study foods 
 
-Bruising and discomfort from heart health measures 
 
-Pain, discomfort, lightheadedness or dizziness may occur from blood draw 
 
-Embarrassment with fecal collection kit 
 
-Loss of confidentiality 
 
What are the possible benefits to you that may reasonably be expected from being in the research?  
There are no benefits to you from taking part in this research. Results of the study may benefit other people in the 
future by helping us learn more about the role of pecans in management of heart disease and metabolic risk. 
 
What happens if you do not want to be in this research? 
You may choose not to take part in this research study. 
 
1. Why is this research study being done? 
 
We are asking you to participate in this research to study how including 2 oz./day of pecans in your 
diet or continuing your current diet affects risk factors for heart disease and diabetes. We will be 
measuring the effect on heart health, blood pressure, blood cholesterol and glucose levels, and gut 
health. 
 
This research is being done because approximately 50% of Americans are at risk for heart disease and 
diabetes and therefore strategies are needed to lower risk. Pecans are a nutrient rich food that may help to 
reduce the risk of these diseases. However, studies to date have not examined the effect of incorporating  
pecans in the diet on diet quality and risk factors for heart disease and diabetes.  
 
Approximately 128 people will take part in this research study conducted at the Pennsylvania 
State University, University Park Campus, PA. 
 
2. What will happen in this research study? 
 


Page 4 of 14 (v.4/22/2022) 
 
 
General overview of the study 
 
If you agree to participate in this study, your participation will last approximately 12 weeks in total. In this 
study, participants will be allocated to one of two groups. The allocations will be made randomly, similar to 
tossing a coin. If you are in group 1, you will be provided with two ounces of pecans per day and be asked to 
consume this in place of the snacks that you usually consume for the entire 12-week period. The pecans will 
be provided by the research team. If you are in group 2, you will be asked to continue eating your usual diet 
and make no changes during the 12-week period. You will be given $30 worth of gift cards per month, which 
is equal to the value of the pecans group 1 will receive. Regardless of whether you are in group 1 or 2, you are 
required to come to campus monthly to receive the pecans or gift cards and to complete questionnaires. You 
will also receive biweekly compliance phone calls. Throughout the entire study we will ask that you do not 
consume peanuts or tree nuts other than the ones we give you. This is not a weight loss study, so you must 
try to keep your body weight and physical activity level constant throughout the entire study. 
 
Procedures to be followed 
 
Screening: 
This visit will consist of filling out forms (medical history, personal information); measuring height and 
weight so that body mass index (BMI) can be calculated; measuring waist circumference, and blood pressure 
to determine eligibility. A blood sample will be taken from a forearm or hand vein and a complete blood 
count, including liver and kidney function and a blood fat panel will be performed (approximately 19 ml of 
blood or 1.25 tablespoons will be taken). You will feel a small pinch or discomfort when the needle is 
inserted. If the initial blood draw is unsuccessful it may need to be repeated, with your permission. If you 
take thyroid medicine, and do not have a current lab test (within 6 months), we will draw 3.5 ml (0.2 Tbsp) 
more blood to conduct a thyroid test. If you are female of child bearing potential, you will be given a urine 
pregnancy test. You will be contacted within 3-5 days with the results of the screening blood sample. A 
clinician at the CRC will review all of the screening data and based on this the research team will determine 
your eligibility. If you are eligible for the study, you will be contacted to schedule your start date and 
baseline data collection appointments. There will be no charge for the screening blood work or 
measurements.  You will receive these results. If you agree to continue your participation in this study, you 
will agree to check with the study staff before participating in any other research studies; the study 
coordinator will determine if you can participate. 
 
Baseline and endpoint testing 
At the beginning and end of the study (12-weeks) you will have your weight and waist circumference 
measured. If you are female of childbearing potential, you will be given a urine pregnancy test. 
 
Blood sampling: 
 
You cannot consume any food or drinks except for water for 12 hours, and cannot drink alcohol during 
the 48 hours prior to having your blood taken. 
 
In addition to the blood taken at screening, blood samples will also be taken on two consecutive days at the 
beginning and end of the study (12-weeks). After a 12 hour fast (consumption of no food or drink except 
water), a blood sample will be taken from your arm. If the initial blood draw is unsuccessful it may need to 
be repeated, with your permission. Approximately 60 ml (about 4 tablespoons) of blood will be collected 
over the two days of testing (30 ml or 2 tablespoons each day). Therefore, over the ~12-week study, blood 
will be taken 4 times with a total amount of approximately 120 ml (8 tablespoons). A typical American Red 
Cross blood donation is 1 pint (473 ml). Blood samples will be frozen and analyzed at the end of the study 
(when all of subjects have completed the study). The results of the study will only be available at the end of 


Page 5 of 14 (v.4/22/2022) 
 
 
the study (which may take up to 3 years). Your blood may be tested for the following: blood fats (total 
cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), blood sugar (glucose, fructosamine, HbA1c), 
insulin, and markers of inflammation or other measures related to risk for heart disease or diabetes. No 
personal information will be kept with any sample – only ID# assignments – and only the Primary Investigator, 
co-investigator and study personnel will have access to the ID# assignments with the study files. 
 
Measures of vascular (heart) health: 
 
Flow mediated Dilation: 
Pre-menopausal women will be scheduled for testing within 7 days of starting their menstrual period to 
control for hormonal effects on vascular function. 
 
At the beginning and end of the study (12-weeks) you will undergo a test that determines the health of your 
arteries. This test will be performed using an ultrasound machine. 
 
Ultrasound is often used to see images of babies in the womb. We will use ultrasound to measure the 
diameter of an artery in your upper arm, before and after the inflation of a blood pressure cuff on the 
forearm. In most people, this procedure produces dilation (opening up) of the artery. 
Ultrasound will be used to collect images of the brachial artery in your right arm. This procedure is known 
as Flow Mediated Dilation (FMD). The FMD test takes about 30 minutes and is performed as follows: 
1. In a private room, you may be asked to remove your shirt and put on a hospital gown. (You will not 
be asked to remove any clothing below the waist). You will lie quietly on a bed in a quiet, darkened 
room. 
2. Your right arm will be extended at a 45-degree angle from your shoulder and rest on some foam 
cushion supports. A blood pressure cuff will be placed on your forearm. 
3. A research assistant will place 3 EKG electrodes (stickers) on your upper chest and stomach. 
4. You will be asked to rest for 5 minutes. 
5. A technician, trained in medical ultrasound, will sit at the head of the bed. The technician will apply 
ultrasound gel on your arm and will place an ultrasound probe (which looks like a microphone) on 
that arm. 
6. An image of the blood vessels in your arm will be viewed on the ultrasound equipment next to the 
bed. The technician may need to move the probe over a small area of your upper arm to obtain the 
clearest image. The image of the artery will be videotaped for 1 minutes. 
7. Next, the blood pressure cuff on your lower arm will be tightly inflated (to a pressure of 250 mmHg) 
and it will remain inflated for 5 minutes. 
8. While the cuff remains inflated, the technician will continue to record the image of the artery in your 
upper arm. At the end of 5 minutes, the cuff will be deflated and images will be captured and 
recorded for an additional 2 minutes. It is very important throughout the recording that you rest 
quietly and keep your arm as still as possible. 
 
Pulse wave analysis (PWA) and Pulse Wave Velocity (PWV): 
You will undergo a test that measures your blood pressure and pulse wave forms at the beginning and end 
of the study (12-weeks). The PWA measurement is very similar to a routine blood pressure measurement. 
Prior to the measurement, you will be asked to sit quietly with your feet flat on the floor for at least 5 
minutes. A blood pressure cuff will be placed on your upper arm. The cuff will inflate, then deflate for 5 
seconds, and then partially re-inflate. It is important that you remain still during this measurement. The 
procedure will be repeated twice, for a total of 3 measurements. Repeated measurements are used to 
increase accuracy. For the PWV measurement, we will ask you to lay flat on a hospital bed without a pillow. 
A blood pressure cuff will be placed on your upper leg. We will gently place a hand-held sensor against an 
artery in your neck. This will measure the pressure waves of the blood in your artery. Once a good waveform 


Page 6 of 14 (v.4/22/2022) 
 
 
is obtained, the blood pressure cuff on your leg will inflate to measure the pressure waveforms in that artery. 
Having these simultaneous measurements allows the device to calculate the speed at which blood is traveling 
through your arteries. The PWV test will also be performed three times. 
 
Fecal collection: 
At the beginning and end of the study (12-weeks) you will be asked to collect a fecal sample (~50 g). You 
will be provided with a stool sample kit and detailed instructions for collection of a clean sample at home. 
The samples will be stored for possible future analysis of amount and number of different bacteria in 
your stool samples as a measure of your gut microbiome. 
 
Dietary intake: 
You will be asked to complete three, 24-hour dietary recalls at the beginning of the study, in week 
6 of the study and in week 12 of the study; a total of 9 recalls. You will complete these recalls using 
an online system (Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool) at 
home or at the Clinical Research Center. Study staff will provide you with a login code and you 
will be asked to provide information about the foods, beverages, and supplements you consumed 
during the previous day. These will be completed at home. 
 
Monthly Metabolic Diet Center Visits: 
At the end of your second day of baseline testing, you will be asked to go to the Metabolic Diet Center to 
collect your study food or gift card as well as a compliance sheet. You will be asked to fill this sheet out daily 
and adhere to the instructions provided. These meetings will be coordinated through the Diet Center 
Manager Marcella Smith: 814-863-9745 (office) 814-280-0136 (cell). 
 
 
3. What are the risks and possible discomforts from being in this research study? 
 
Dietary intervention 
You will be asked to report any food allergies during the telephone screening, however, it is possible that 
an unknown food allergy may manifest during the study. This is most likely to occur within the first week of 
the study since the pecans will be eaten daily. It is unlikely that you will experience any discomfort with the 
addition of pecans. However, you may have an unknown sensitivity to this amount of pecans that may cause 
you to experience GI (stomach) upset such as bloating, diarrhea, or gas. You should report any adverse 
reactions to study personnel. 
 
Food preparation 
The pecans will be handled according to accepted standards of sanitation and provisions are made to ensure 
the safety of the pecans provided for off-site consumption. However, it is possible that incorrect food 
handling during shipping, storage or preparation, if not detected, could result in food-borne illness. Every 
effort will be made to safeguard against this possibility. To date, no food related contamination or illnesses 
have occurred. 
 
Blood Sampling 
Blood draws often cause mild pain, swelling or bleeding. There may be some bruising (blood under the 
surface of the skin), which will be minimized by pressing on the site after the needle is removed. There is 
also a slight chance of infection, dizziness or fainting. These risks will be minimized and most likely eliminated 
by having trained nursing staff draw the blood in a clinical setting using sterile supplies. If dizziness or fainting 
occurs, the symptoms will be alleviated by having you lie flat with your feet raised. The nursing staff will ask 
that you remain at the clinic until your blood pressure has been checked and you are cleared from any further 
risk. 


Page 7 of 14 (v.4/22/2022) 
 
 
 
Vascular Ultrasound Test (FMD) 
There are no known risks associated with ultrasound. However, because the blood pressure cuff on your 
right forearm is inflated tightly, it is likely that your hand and arm below the blood pressure cuff will 
experience “pins and needles” (tingling and pricking) sensations while the cuff is inflated and for a few 
minutes after it is released. This feeling is similar to what you feel when your hand or foot “falls asleep.” 
During the 5 minutes that the blood pressure cuff is inflated on your forearm, your arm could become numb 
and we will ask you not to move it. This might be moderately painful. However, any discomfort or 
numbness should go away within minutes of cuff deflation and there are no known long-term risks 
associated with this test. There is a possibility for red blotching or mild bruising (petechiae) to appear on 
the skin above and below the location of the blood pressure cuff. Studies indicate that petechiae are rare 
(occurring in less than ½ of 1% of patients) and it is typically not uncomfortable and it does not require 
treatment. There are no risks associated with measurement of blood pressure, heart rate, or EKG as long as 
you are not allergic to adhesive tape. Temporary redness at the site of the electrode placement is possible. 
 
All recordings from the ultrasound will have no personal identifying information associated with them and 
will be stored in a secure, password-protected folder only accessible by approved study personnel. 
 
Pulse Wave Analysis (PWA) and Pulse Wave Velocity 
There are no known risks associated with these measurements. There will be a sensation of pressure from 
the blood pressure cuff. There is a possibility for red blotching or mild bruising (petechiae) appearing on the 
skin above and below the location of the blood pressure cuff. Studies indicate that petechiae are rare and 
typically not uncomfortable and do not require treatment. 
 
Loss of Confidentiality 
There is a risk of loss of confidentiality if your information or your identity is obtained by someone other 
than the investigators, but precautions will be taken to prevent this from happening.  The confidentiality 
of your electronic data created by you or by the researchers will be maintained as required by applicable 
law and to the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed. 
 
Stool collection 
You may experience some level of embarrassment or discomfort from being asked to collect stool samples. 
However, you will be provided with detailed instructions on how to collect the samples within the comfort 
of your own home, and at your convenience, to help reduce any concerns you may have. 
 
4. What are the possible benefits from being in this research study? 
4a. What are the possible benefits to  you? 
Participants will receive their screening laboratory results, including a complete blood count, 
interpretation of liver and kidney function, and blood lipid values, at no cost. 
 
4b. What are the possible benefits to others? 
The study may provide information related to the role of pecans in management of heart disease and 
metabolic disease risk factors.  
 
5. What other options are available instead of being in this research study? 
You may decide not to participate in this research. 
 
6. How long will you take part in this research study? 
The study period is approximately 12 weeks. Pre-menopausal women will be scheduled for testing within 
7 days of starting their menstrual period to control for hormonal effects on vascular function.  


Page 8 of 14 (v.4/22/2022) 
 
 
 
You will be expected to go to the Metabolic Diet Center on campus monthly for compliance monitoring 
and provision of the pecans or gift card as well submission of a compliance tracking sheet. At the beginning 
of the study and at 12 weeks, endpoint data will be collected. 
 
Total time for study visits, after the initial screening is approximately 4 hours. Times may vary and females 
will require an additional 5 minutes for a urine pregnancy test at baseline and the end of each diet period. 
The following is an estimate of the amount of time you will spend in study activities: 
 
Screening appointment:   
Day 1: Forms, blood pressure, weight, height, waist circumference, blood draw – 45-60 minutes  
(pregnancy testing: females only – 5 minutes)  
 
Beginning of treatment period: 
Day 1: blood draw, weight, waist circumference, vascular testing– 60 minutes   
(pregnancy testing: females only – 5 minutes)  
Day 2: blood draw, vascular testing– 45 minutes   
 
End of treatment period (week 12):  
Day 1: blood draw, weight, waist circumference, vascular testing– 60 minutes   
(pregnancy testing: females only – 5 minutes)  
Day 2: blood draw, vascular testing – 45 minutes   
 
Picking up food/gift card and compliance questionnaires and compliance calls, fecal collections, 
and completing 24-hour diet recalls: ~ 7 hours  
  
 
 
Total time for clinic and diet center visits from the beginning to the end of the study ~12 hours  
  
7. How will your privacy and confidentiality be protected if you decide to take part in this research 
study? 
Efforts will be made to limit the use and sharing of your personal research information to people who have 
a need to review this information. 
• 
An electronic list that matches your name with your code number will be saved in a secure, 
password-protected folder where only approved study personnel will have access. 
• 
Your research records will be labeled with a unique ID number and will be kept locked at the PI’s 
research office. All electronic records will be saved to a secure, password-protected folder only 
accessible by approved study personnel. All records associated with your participation in the study 
will be subject to the usual confidentiality standards applicable to medical records. 
• 
Your research samples will be labeled with your unique ID number and will be stored in locked 
freezers at the CRC and in 318 Chandlee Lab. They will be maintained until three years after the 
date when the study is published, and then destroyed unless you give permission for us to keep 
your blood samples for future use (see end of document). 
 
For research specimens sent to other laboratories or facilities for analysis, no personal identifiable 
information will be used. Samples will be labelled only with ID numbers. Blood samples will be sent 
to LabCorp, Morrisville NC. Fecal samples will be sent to Wright Labs LLC, Huntingdon PA. 
 
In the event of any publication or presentation resulting from the research, no personally identifiable 
information will be shared. 


Page 9 of 14 (v.4/22/2022) 
 
 
 
We will do our best to keep your participation in this research study confidential to the extent permitted by 
law. However, it is possible that other people may find out about your participation in this research study. 
For example, the following people/groups may check and copy records about this research. 
• 
The Office for Human Research Protections in the U. S. Department of Health and Human Services 
• 
U.S. Food and Drug Administration 
• 
The research study sponsor, the American Pecan Council 
• 
The Institutional Review Board (a committee that reviews and approves research studies) and 
• 
Penn State’s Office for Research Protections. 
 
Some of these records could contain information that personally identifies you. Reasonable efforts will be 
made to keep the personal information in your research record private. However, absolute confidentiality 
cannot be guaranteed. 
 
7b. What will happen to my research information and/or samples after the study is completed? 
In the optional portion of the consent form, we will ask for your permission to use or share your identifiable 
research information and blood and fecal samples with other investigators here or at other institutions. 
Future research may be similar to this study or completely different. You can be part of the current study 
without agreeing to the future use of your identifiable research information and your biological samples 
(blood and fecal). 
 
8. What happens if you are injured as a result of taking part in this research study? 
In the unlikely event you become injured as a result of your participation in this study, medical care is 
available. It is the policy of this institution to provide neither financial compensation nor free medical 
treatment for research-related injury. By signing this document, you are not waiving any rights that you 
have against The Pennsylvania State University for injury resulting from negligence of the University or 
its investigators. 
 
9. Will you be paid or receive credit to take part in this research study? 
For your participation in this study you will receive monetary compensation of $200, prorated as follows 
and paid at the end of your participation in the study. If you drop out of the study for any reason before 
its completion, the following compensation will be provided: 
 
Completion of day 1 and day 2 testing at baseline = $50 
Completion of three 24-hour recalls at baseline= $25 
Completion of three 24-hour recalls at week 6 = $25 
Completion of day 1 and day 2 testing at 12 weeks = $75 
Completion of three 24-hour recalls at week 12 = $25 
 
The total of $200 will be paid at the completion of the participant’s involvement with the study. 
 
If you are a Penn State employee, you will be asked to provide your name and Penn State ID number 
and payment will be provided by direct deposit via the payroll system. If you are not a Penn State 
employee, you will be paid by check and your Social Security Number must be collected for tax reporting 
purposes. The compensation that you receive for participation in this study is taxable income. 
 
Total payments within one calendar year that exceed $600 will require the University to report these 
payments to the IRS annually. This may require you to claim the compensation that you receive for 
participation in this study as taxable income. 
 


Page 10 of 14 (v.4/22/2022) 
 
 
If determined that specific work or visa laws conflict, participants may not be eligible for compensation. 
Participants can discuss this with the research team for more information. 
 
10. Who is paying for this research study? 
 The sponsor, the American Pecan Council is paying PSU for the research to be done. 
 
11. What are your rights if you take part in this research study? 
Taking part in this research study is voluntary. 
▪ You do not have to be in this research. 
▪ If you choose to be in this research, you have the right to stop at any time. 
▪ If you decide not to be in this research or if you decide to stop at a later date, there will be no penalty 
or loss of benefits to which you are entitled. 
▪ If you stop being in the research, already collected data may not be removed from the study 
database. 
The person in charge of the research study or the sponsor can remove you from the research study 
without your approval. Possible reasons for removal include non-compliance with the study protocol 
(consuming treatment foods) or study visits (attending clinic visits). 
 
During the course of the research you will be provided with any new information that may affect your 
health, welfare or your decision to continue participating in this research. 
 
12. If you have questions or concerns about this research study, whom should you call? 
Please call the head of the research study (principal investigator), Dr. Kristina Petersen, at 814-865-7206if you: 
▪ 
Have questions, complaints or concerns about the research, including questions about compensation. 
▪ 
Believe you may have been harmed by being in the research study.   
 
You may also contact the Office for Research Protections at (814) 865-1775, IRB-ORP@psu.edu if you: 
▪ 
Have questions regarding your rights as a person in a research study. 
▪ 
Have concerns, complaints, or general questions about the research.  
▪ 
You may also call this number if you cannot reach the research team or wish to offer input or to talk to 
someone else about any concerns related to the research.  
 
You may visit the Office for Research Protections’ website at https://www.research.psu.edu/irb/participants 
for: 
▪ 
Information about your rights when you are in a research study;  
▪ 
Information about the Institutional Review Board (IRB), a group of people who review the research to 
protect your rights; and  
▪ 
Links to the federal regulations and information about the protection of people who are in research 
studies. If you do not have access to the internet, copies of these federal regulations are available by 
calling the ORP at (814) 865-1775. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This 
Web site will not include information that can identify you. At most, the Web site will include a summary of the 
results. You can search this Web site at any time. 
 
 
INFORMED CONSENT TO TAKE PART IN RESEARCH 
 
Signature of Person Obtaining Consent 
 


Page 11 of 14 (v.4/22/2022) 
 
 
Your signature below means that you have explained the research to the subject or subject 
representative, provided the subject or subject representative an opportunity to discuss 
and consider whether or not to participate in the research, and have answered any 
questions the subject or subject representative has about the research.  
 
 
Signature of person obtaining consent   Date 
Printed Name 
(Only approved investigators for this research may explain the research and obtain informed consent.) 
 
 
Before making the decision about being in this research you should have: 
• 
Discussed this research study with an investigator, 
• 
Read the information in this form, and 
• 
Had the opportunity to ask any questions you may have. 
Your signature below means that you have received this information, have asked the questions you currently 
have about the research and those questions have been answered. You will receive a copy of the signed and 
dated form to keep for future reference. 
 
Signature of Subject 
 
By signing this consent form, you indicate that you voluntarily choose to be in this research and agree to 
allow your information to be used and shared as described above. 
 
 
Signature of Subject 
Date 
Printed Name


Page 12 of 14 (v.4/22/2022) 
 
 
Optional part(s) of the study 
In addition to the main part of the research study, there is another part of the research. You can be in 
the main part of the research without agreeing to be in this optional part. 
 
Optional Storage of Tissue for Future Research 
In the main part of this study, we are collecting blood samples and fecal samples from you. If you agree, the 
researchers would like to store leftover sample(s) for future research. 
• 
These future studies may be helpful in understanding heart disease and diabetes. 
• 
It is unlikely that these studies will have a direct benefit to you. 
• 
Neither your doctor nor you will receive results of these future research tests, nor will the results be 
put in your health record. 
• 
Sometimes tissue is used for genetic research about diseases that are passed on in families. Even if 
your samples are used for this kind of research, the results will not be put in your health record. 
 
Your leftover samples will be labeled with a code number that will be linked to a master list accessible only to 
the PI, co-investigator and research team. This list will be destroyed 3 years after publication of the study 
results. These samples will be stored in a locked freezer in a locked office of the PI’s. 
• 
The length of time they will be used is unknown. 
• 
You will be free to change your mind at any time before the master list is destroyed (approximately 
3 years after publication of the study results) at which point we will no longer be able to identify 
your samples. 
• 
You should contact the principal investigator if you wish to withdraw your permission for your blood 
samples or fecal samples to be used for future research. If it is still possible to identify your samples, 
any unused samples will be destroyed and not used for future research studies. 
 
You should initial below to indicate what you want regarding the storage of your leftover blood samples 
and fecal samples for future research studies. 
 
a. Your samples may be stored and used for future research studies to learn about diabetes and heart 
disease prevention. 
  
Yes 
  
No 
 
c. Your samples may be shared with other investigators/groups without any identifying information. 
  
Yes 
  
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 13 of 14 (v.4/22/2022) 
 
 
Signature of Person Obtaining Consent 
 
Your signature below means that you have explained the optional part(s) of the research to the subject 
or subject representative and have answered any questions he/she has about the research. 
 
 
Signature of person obtaining consent   Date 
Printed Name 
 
 
Signature of Subject 
By signing below, you indicate that you have read the information written above and have indicated your 
choices for the optional part(s) of the research study. 
 
 
Signature of Subject 
Date 
Printed Name 
 
 
 
Future Contact 
 
Do we have permission to keep your personal information and contact you about your interest in 
participating in future studies for Dr. Petersen and her collaborators? 
 
  
Yes 
  
No 
 
Signature of Person Obtaining Consent 
 
Your signature below means that you have explained the optional part(s) of the research to the subject 
or subject representative and have answered any questions he/she has about the research. 
 
 
Signature of person obtaining consent                         Date 
Printed Name 
 
Signature of Subject 
By signing below, you indicate that you have read the information written above and have indicated your 
choices for the optional part(s) of the research study. 
 
 
Signature of Subject 
 
 
          Date 
 
 
 
Printed Name 
 

SAP_005.pdf: 
 
 
 
 
 
 
 
 
 
Cardiometabolic Effects of Pecans as a Snack 
NCT05071807 
September 19, 2023 
 
 
 
 
 
 
 
 
 
 
 
 


The sample size calculation was based on FMD, the primary outcome. To detect a 1.2 percentage point 
(standard deviation 2.4; effect size 0.5) between-group difference in the change in FMD with 80% power 
(α=0.05), it was estimated that a sample size of 128 participants was needed (64 per group) (40-43).  
All analyses were performed in SAS (version 9.4; SAS Institute Inc.). All data collected from randomly 
assigned participants were included in data analyses consistent with intent-to-treat principles. All 
residuals for regression models were checked for normality via normal probability (Q-Q) plots. When the 
residuals were non-normally distributed, log transformation was conducted, which improved the 
residual distribution to approximately normal. Linearity was investigated by plotting model residuals 
against the outcome of interest and for all variables the assumption of linearity was met. All models 
were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2). 
For all described tests, effect modification by sex was examined by evaluating the group by sex 
interaction. If the group by sex interaction main effect was not significant it was excluded from the final 
model. The primary analyses for the vascular and cardiometabolic outcomes assessed between group 
(pecan or usual diet) differences in the change from baseline. The change from baseline was calculated 
by subtracting the endpoint value from the baseline value. Weight, lipids/lipoproteins, glucose and 
insulin were measured on two test days at each time point and values were averaged for analysis to 
improve measurement precision. Between-group differences in the change from baseline for all vascular 
and cardiometabolic outcomes were assessed using linear regression models.  
For diet quality, linear mixed models were used to account for the repeated nature of the outcome. 
Group was included as a fixed effect and time point was included as a repeated effect. Intervention 
effects were determined by examining the group by visit interaction. When a significant group by time 
point interaction was detected, post hoc testing was conducted and the Tukey-Kramer method was used 
to adjust for multiple comparisons. Statistical significance was set at p <0.05.