Glycemic Effects of Substituting Pecans for Snacks Higher in Saturated Fat and Added Sugars in Individuals With Prediabetes
Phase: NA
Conditions: Prediabetes
Sponsor: Penn State University

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HRP-591 - Protocol for 
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). 
Glycemic effects of substituting pecans for snacks higher in saturated fat and added sugars in individuals with 
prediabetes
Principal Investigator:
Name: Dr. Kristina Petersen
Department: Nutritional Sciences
Telephone: 814-863-7206
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. 
4/3/26
Clinicaltrials.gov Registration #:
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual”, under 
“ClinicalTrials.gov” for more information. 
NCT07235358
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 INSTRUCTIONS1:  
•
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.
•
CHECKBOXES: Either check the boxes or indicate an “X” before the checkbox.  Do NOT delete checkboxes.
•
The protocol should be written in lay language. Do NOT copy and paste grant proposal information into the 
protocol.
1 This template satisfies AAHRPP elements 1.7.B, I.8.B, I-9, II.2. A, II.2.I, II.3.A, II.3.B, II.3.C-II.3.C.1, II.3.D-F, II.4.A, III.1.C-F, II.2.D 
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•
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: 
Human Research Protection Program
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
https://researchsupport.psu.edu/orp/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
References
21.0
Confidentiality, Privacy and Data Management
22.0
Identifiable Data and Specimen Banking for Future Undetermined Research
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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 overarching goal of this study is to evaluate the glycemic and cardiovascular effects of substituting 
pecans for snacks higher in saturated fat and added sugars in individuals with prediabetes. To achieve 
this, a 16-week, 2-arm parallel, randomized controlled trial in adults with prediabetes will be conducted. 
Participants will be randomized to one of two groups: 1) provision of 1.5 oz/day of pecans with 
education to consume these instead of their currently consumed snacks higher in saturated fat and 
added sugars (intervention); 2) continuation of their habitual diet (control). The study aims to assess the 
effect of the intervention compared to the control on the following outcomes: 
1. Markers of glycemic control, including hemoglobin A1C (HbA1C), fasting glucose, fasting 
insulin, homeostatic model of insulin resistance (HOMA-IR), lipoprotein insulin resistance index, 
mean glucose, time in range, glycemic variability, and insulin resistance.
2. Markers of cardiovascular health, including lipid/lipoprotein concentrations, lipoprotein 
particle size and concentrations, apolipoprotein B, blood pressure, C-reactive protein (CRP), and 
vascular health.
3. Dietary intake of saturated fat and added sugars, and overall diet quality. 
It is hypothesized that replacement of usual snacks higher in saturated fat and added sugars with pecans 
will improve glycemic control, cardiovascular health, intake of saturated fat and added sugars, and 
overall diet quality compared to continuing usual intake after 16 weeks in adults with prediabetes. 
Therefore, this trial is expected to show that dietary substitution of commonly consumed unhealthy 
snacks with pecans improves blood sugar control and cardiovascular health thus potentially reducing 
disease risk. The results of the study are expected to inform dietary guidance about the types of snacks 
that can be included in healthy dietary patterns.
1.2
Primary Study Endpoints
State the primary endpoints to be measured in the study.  
Research typically has 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).
Hemoglobin A1C (HbA1C) 
1.3
Secondary Study Endpoints
State the secondary endpoints to be measured in the study.
Fasting glucose and insulin
Homeostatic model of insulin resistance (HOMA-IR)
Continuous glucose monitor (CGM) assessed mean glucose, time in range, and glycemic variability
Lipid/lipoprotein concentrations (triglycerides, total cholesterol, LDL-C, HDL-C, non-HDL-C)
Apolipoprotein B, lipoprotein particle size and concentration (LDL, HDL, triglyceride-rich lipoproteins)
Lipoprotein insulin resistance index
C-reactive protein
Central and peripheral blood pressure
Pulse wave velocity (PWV)
Saturated fat and added sugar intake
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Overall diet quality, assessed by the Healthy Eating Index 2020
2.0
Background 
2.1
Scientific Background and Gaps
Briefly describe the scientific background and gaps in current knowledge in lay language. 
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 
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.
Approximately 38% of US adults have prediabetes.1 Prediabetes is defined by the American Diabetes 
Association as a condition that precedes type 2 diabetes and is diagnosed by elevated HbA1C (5.7-6.4%), 
impaired fasting glucose (100-125 mg/dL), or impaired glucose tolerance assessed with a 75 g oral 
glucose tolerance test.2 Individuals with prediabetes are at high risk for type 2 diabetes. For individuals 
with prediabetes at age 45 years, the lifetime risk of type 2 diabetes is 74%; the risk is higher for those 
with concomitant obesity.3 In addition, prediabetes is associated with a heightened risk of 
cardiovascular disease (CVD).2 Therefore, the goal of prediabetes management is to improve glycemic 
control to reduce the risk for progression to type 2 diabetes and the associated complications, including 
CVD risk.2 
A key component of prediabetes management is intake of a healthy dietary pattern that emphasizes a 
variety of nutrient-dense foods to support glycemic control as well as cardiovascular health.4 In the U.S., 
adherence to healthy dietary patterns is poor.5 Therefore, strategies are needed to improve adherence 
to healthy dietary patterns. 
In the U.S., snacks comprise ~20% of daily total energy intake6. While intake of nutrient-rich snacks is 
associated with better adherence to healthy dietary patterns, intake of snacks high in added sugars and 
saturated fat contributes to poorer adherence to healthy dietary patterns.7,8 Therefore, replacing 
nutrient-poor snack foods with nutrient-dense alternatives may be a feasible strategy to improve 
adherence to healthy dietary patterns, which may assist with improving glycemic control and reducing 
CVD risk in individuals with prediabetes. 
Nuts are a nutrient-dense food that are a recommended part of healthy dietary patterns4,9,10 and nut 
intake is associated with better adherence to healthy dietary patterns.8 Consistent evidence from 
epidemiological studies shows that higher nut intake is associated with lower risk of CVD.11 This is 
supported by clinical trial evidence showing nut intake improves CVD risk factors, including low-density 
lipoprotein cholesterol (LDL-C), triglycerides12,13, and glycemic control.14,15 Prior clinical trials show 
pecans improve lipids and lipoproteins compared to non-nut comparators after 4-8 weeks16–21.
2.2
Previous Data
Describe any relevant preliminary data.
In a randomized controlled trial conducted by the PI, it was demonstrated that instructions to eat 2 
oz/day of pecans as a replacement for usual snacks improved LDL-cholesterol (-7.2 mg/dL; 95% CI -12.3, 
-2.1), non-HDL-cholesterol (-9.5 mg/dL; 95% CI -15.3, -3.7) and apolipoprotein B (-4.38 mg/dL; 95% CI -
8.02, -0.73) after 12 weeks, compared with continuing usual intake, in adults at risk for cardiometabolic 
diseases.20,21 We also observed an improvement in total LDL particles and total triglyceride-rich 
lipoprotein particles (TRL-P) as well as an improvement in the lipoprotein insulin resistance index, which 
is indicative of a reduction in early insulin resistance.20,21 In addition, replacement of typical snacks with 
pecans increased overall diet quality, assessed by the Healthy Eating Index-2020 (a measure of 
adherence to the Dietary Guidelines for Americans), by 9.4 points (95% CI 5.0, 13.7) compared to the 
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usual diet group.20 Collectively, this trial showed that instructions to replace all typical snacks with 
pecans for 12 weeks improved lipoproteins, early insulin resistance, and diet quality in people at risk for 
cardiometabolic diseases. Importantly, the lipid/lipoprotein, insulin resistance, and diet quality 
improvements observed with replacing all snacks with 2 oz/day of pecans were greater20,21 than we have 
observed previously in studies examining the replacement of evening snacks only with peanuts (1 
oz/day)22 and pistachios (2 oz/day).23 In these trials, replacing all snacks20,21 or evening snacks only22,23 
with nuts did not consistently improve glycemic control, which is generally consistent with evidence on 
the glycemic effects of nuts.14 However, previously replacement of snacks higher in saturated fat and 
added sugars with nuts has not been examined. 
2.3
Study Rationale
Provide the scientific rationale for the research.
It is established that replacement of carbohydrates, including added sugars, and saturated fat with 
unsaturated fats improves glycemic control assessed by HbA1C. In a meta-analysis of 102 randomized 
controlled feeding trials, replacement of 5% of energy from carbohydrates with monounsaturated fatty 
acids (MUFA; -0.09%; 95% CI -0.12, -0.05) or polyunsaturated fatty acids (PUFA; -0.11%; 95% CI -0.17, -
0.05) improved HbA1C.24 Similarly, replacement of SFA with MUFA (-0.12; 95% CI -0.19, -0.05) or PUFA (-
0.15; 95% CI -0.23, -0.06) reduced HbA1C.24 More recently, in a 12-week randomized controlled trial in 
individuals with overweight or obesity, intake of 1 avocado per day lowered HbA1C by 0.06% after 12 
weeks compared to a low-fat, higher carbohydrate food.25 Thus, it is likely that education to consume 
pecans, which are low in carbohydrates and rich in unsaturated fats, instead of snacks higher in 
saturated fat and added sugars, will improve glycemic control, particularly in individuals with 
prediabetes defined by elevated HbA1C. 
Therefore, this trial aims to evaluate the glycemic and cardiovascular effects of substituting pecans for 
snacks higher in saturated fat and added sugars, compared to continuing usual intake, in individuals with 
prediabetes. The intent of this study is not to evaluate pecans’ ability to cure, mitigate, treat, or prevent 
disease. Rather, the intent is to see whether education to replace snacks higher in added sugars and 
saturated fat with pecans improves glycemic control and cardiovascular health, compared to continuing 
usual intake, in individuals with prediabetes. This evidence is expected to contribute to understanding 
the role of snacking in cardiometabolic health and inform dietary guidelines. 
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:
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”
•
Adults with Impaired Decision-Making Capacity - Review “HRP-417- Checklist - Adults with Impaired 
Decision-Making Capacity” 
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•
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.)
All the following inclusion criteria must be met at screening to be eligible for the study:
•
Age 25-65 years
•
Prediabetes assessed by an HbA1c of 5.7-6.4% at screening
•
BMI 25-40 kg/m2 at screening
•
Low habitual nut consumption (<3.5 oz-eq/week) assessed at the telephone screening
•
Regularly eats snacks higher in saturated fat and/or added sugars assessed at the telephone 
screening
3.1.1
Does this research involve collecting data from individuals residing outside of the US?
  No
  Yes – identify the countries where data collection will take place
[Type protocol text here] 
3.2
Exclusion Criteria
Create a numbered list of the exclusion criteria that define who will be excluded in your study.
None of the following exclusion criteria must be met at screening to be eligible for the study:
•
LDL-C ≥190 mg/dL at screening
•
Hemoglobin <13.2 g/dL at screening
•
Fasting triglycerides >350 mg/dL at screening
•
≥10% change in body weight within the 6 months prior to enrollment
•
Blood pressure >140/90 mmHg at screening
•
Type 1 or type 2 diabetes
•
Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs
•
Intake of supplements that affect the outcomes of interest (i.e., lipid, blood pressure, or glucose 
lowering; vitamin C or multi-vitamins containing vitamin C) and are unwilling to cease during the 
study period. Eligible if willing to discontinue. If willing to discontinue, the following washout 
period should be adhered to:
Washout prior to screening visit: 
2-weeks for vitamins, probiotics, fermented drinks (e.g. kefir, kombucha)
2-weeks for omega 3 supplements ≤2 g/day 
4-weeks for omega 3 supplements >2g/day
Washout prior to baseline visit:
4-weeks for probiotics, fermented drinks, vitamins, and omega-3 supplements ≤2g/day 
6 weeks for omega-3 supplements >2g/day
•
History of liver, kidney, or autoimmune disease
•
Prior cardiovascular event (e.g., stroke, heart attack)
•
Current pregnancy or intention of pregnancy within the next 12 months
•
Lactation within the prior 6 months
•
Pecan allergy/intolerance/sensitivity/dislike
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•
Antibiotic use within the prior four weeks
•
Oral steroid use within the prior four weeks
•
Use of tobacco or nicotine-containing products within the past 6 months
•
History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or 
non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
•
Participation in another clinical trial within 60 days of baseline
•
Currently following a restricted or weight-loss diet
•
Prior bariatric surgery
•
Intake of >14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 
hours prior to test visits
•
Principal Investigator discretion related to the potential participant’s ability to adhere to the 
study requirements, including being able to come to attend visits
•
Does not speak and/or understand English
•
Unwilling to refrain from donating blood and/or plasma during the study
•
Weight <110 lb
•
Unwilling/unable to eat 1.5 oz of pecans every day as a snack during the duration of the 
study
•
Routine use of OTC medications that affect the outcomes of interest
•
Unwilling to refrain from starting to take any supplements, vitamins, nutritional 
products, or health foods that are not prescribed by a doctor for the duration of the 
study
•
Unwilling to contact study staff before enrolling in other health-related research and 
avoid participating in any research that may interfere with this study
•
For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) 
concentration, or change in dose of thyroid medication within the last 6 months
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.).
Participants will be withdrawn from the study for the following reasons:
•
Risks to the other participants/research team members, disruptive behavior during the 
study visit, or food pick-ups
•
Diagnosis of a disease listed as an exclusion criterion or a serious medical condition 
requiring active intervention (assessed by review of medical history form or participant 
report)
•
Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs (assessed by 
review of medical history form or participant report)
•
Prescription of steroids or antibiotics for longer than 1 week
•
Pregnancy
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; the follow-up for subjects withdrawn from 
investigational treatment.
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No safety concerns; no reason for follow-up. Data from individuals who withdraw from the 
study will be used in an intent-to-treat analysis. 
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]
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, including the description of study procedures, compensation, 
and recruitment, needs to be consistent with information provided on the StudyFinder page in your 
CATS IRB study.
For research utilizing Penn State Health patient data, please note the following:  
o
Submissions using Enterprise Information Management (EIM) for recruitment, and for non-Hershey 
locations as applicable, attach your EIM Design Specification form in CATS IRB (http://irb.psu.edu). 
See “HRP-103- Investigator Manual, Study Recruitment” for additional information. 
o
Direct contact with patients for research recruitment that does not occur in person will require 
review of the contact list by Penn State Health’s Printer Services, see links below. It is the study 
team’s responsibility to assure removal of decedents from the provided data. 
o
Use of Printer Services Instructions  
https://psh.myprintdesk.net/DSF/SmartStore.aspx#!/SearchResults/810-009/false/0 
o
Uploading Files into Printer Services 
https://psh.myprintdesk.net/DSF/SmartStore.aspx#!/SearchResults/Mailing%2520list%2520Scannin
g/false/0. 
Flyers/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 
participants residing in and around the State College area. 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, Viva Engage, and our lab’s PSU webpage) and PSU listservs will be used to 
advertise the study. We will also contact individuals who have participated in previous studies and 
indicated to our research group that they are interested in participating in future studies. Interested 
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individuals will receive an email with additional study information and a link to the pre-screen survey (see 
attachments (Canned email to interested individuals; Pre-screening survey). 
4.2
Recruitment process
Describe how potential subjects first learn about this research opportunity or indicate ‘not applicable’ if 
subjects will not be prospectively recruited to participate 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). 
If applicable, state whether the study team will access medical records before or after engaging the 
potential subject.
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) (see attachment 
Recruitment Advertisements) 
• Recruitment flyers (see attachment Flyers) will have a QR code that can be scanned by 
interested participants and will direct them to the online pre-screening survey via REDCap 
(see attachment Pre-Screening Survey). 
• Email will be used to contact individuals who have participated in previous studies and have 
indicated to our research group that they are interested in participating in future studies (See 
attachment Email for Contacting Previous Subjects).
4.2.2
Where potential subjects will be recruited.
University Park and State College, PA and surrounding areas.
4.2.3
When potential subjects will be recruited.
Recruitment will commence once the protocol is approved and will continue until the target 
sample size is enrolled.
4.2.4
Screening and determining eligibility
Screening involves assessing whether or not a potential subject is eligible for a study based on 
the inclusion and exclusion criteria.  This process only involves assessing eligibility.
 Collecting information/data/biospecimens that are not related to eligibility does not meet the 
definition of screening and requires prior written consent. There are some specific situations in 
which consent is not required prior to screening activities.
  Answer the following items to describe the screening process and determine if prior consent 
and/or HIPAA authorization is required.
4.2.4.1
For the purpose of screening/determining eligibility, is the potential subject providing 
information through oral or written communication (e.g. survey or verbally 
responding to answers)?
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  Yes [NOTE: HIPAA authorization or a waiver of HIPAA authorization may be 
necessary – see section 6.0]  
Participants will complete a REDCap pre-screening survey (see attachment Pre-
Screening Survey) and a telephone screening (see attachment Telephone 
Screening Form) to assess eligibility. Participants will also be asked to complete 
a medical history form (see attachment Medical History Form). The information 
will be recorded and stored by the research team.
Pre-screening survey
Individuals that respond to study advertisements will be directed via an email 
from our lab’s account (dchlab@psu.edu) (see attachment Canned Email to 
Interested Individuals) to complete the online pre-screening survey via REDCap 
(See attachment Pre-Screening Survey). Individuals that call the lab after they 
see a study advertisement will be briefly informed about the study, and their 
name and e-mail address will be requested (see attachment Verbal 
Script_TelephoneCall) so that they can be directed via our lab email to complete 
the online pre-screening survey via REDCap. Individuals that complete the pre-
screening online survey and are eligible based on the included questions, will be 
phone screened for eligibility.
Telephone screening
Individuals who are eligible based on the online pre-screening survey will be 
contacted via our lab’s email (dchlab@psu.edu) (see attachment Canned Email 
to Individuals Eligible for Telephone Screening) to obtain consent for the 
telephone screening. The consent for research screening procedures form will 
be administered via REDCap (see attachment HRP-585 Screening Consent Form). 
Via REDCap, individuals will be prompted to read through the Screening Consent 
Form after which they will be asked to indicate whether or not they consent to 
being called for a telephone screening. If an individual agrees to provide 
consent, they will be prompted to schedule their telephone screening with 
Calendly, an online appointment scheduling tool (https://calendly.com/ket5502-
psu/30min). 
A member of the research team will call individuals that consent to a telephone 
screening call using the contact information provided in the pre-screening 
survey. The telephone screening interview will be conducted according to the 
Telephone Screening Form (see attachment Telephone Screening Form). 
Research staff will either use a paper form or enter data directly into REDCap. 
Based on the answers to the questions, participants deemed eligible will be 
scheduled for a clinic screening visit. Participants eligible for the screening visit 
will receive a confirmation email with the visit instructions at the time the visit is 
scheduled (see attachment Clinic Screening Appointment Confirmation Email), 
and attached to the email will be the written informed consent form (see 
attachment HRP-580 Written Consent Form). Participants will also be asked to 
complete a medical history form via REDCap within 3 days of their screening 
appointment (see attachment Medical History Form), and a reminder will be 
sent via our lab’s email (dchlab@psu.edu) every 24 hours until completion (up 
to 3 total reminders). If participants do not complete the medical history form 
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prior to the screening visit, it will be completed at the screening visit via REDCap 
or using a paper form. 
  
  No
4.2.4.2
Is eligibility being determined by obtaining identifiable private information or 
biospecimens by accessing records or stored identifiable biospecimens?
  Yes [NOTE: HIPAA authorization or a waiver of HIPAA authorization may be 
necessary – see section 6.0]  
[Describe what is being accessed here. Indicate if the information will be 
recorded or stored by the research team.] 
  No 
4.2.4.3
Is the potential subject being asked to do any activity for screening and eligibility 
purposes beyond what is described above (e.g. fast, blood test)?
  Yes [NOTE: consent process or waiver of consent is required – see section 5.0]
Participants will be asked to fast for 12 hours, avoid over-the-counter 
medications and alcohol for 48 hours prior to the clinic screening appointment. 
  No 
4.2.4.4
Is the screening data to be used for purposes other than eligibility or recruitment 
(e.g. retained for data analysis or for other purposes)?
  Yes [NOTE: consent process or waiver of consent is required – see section 5.0]  
The screening data will be retained for data analysis, e.g. describing the 
characteristics of screeners vs. participants that were randomized, completed 
etc. 
  No 
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.
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•
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 (at least one of the first four boxes must be checked):
 Written documentation of consent: Informed consent will be sought and documented with a 
written consent form [Complete Sections 5.2 and 5.6; If this is the only box checked, mark Sections 
5.3, 5.4 and 5.5 as ‘Not applicable’] 
 Waiver of documentation of consent: Informed consent will be sought but subject signature is not 
required (e.g. implied or verbal consent will be obtained) [Complete Sections 5.2, 5.3 and 5.6; If this 
is the only box checked, mark Sections 5.4 and 5.5 as ‘Not applicable’] 
  Alteration of consent process: 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; If 
this is the only box checked, mark Section 5.5 as ‘Not applicable’] 
 Waiver of consent: Informed consent will not be obtained  [Complete Section 5.5; If this is the only 
box checked, mark Sections 5.2, 5.3, 5.4 and 5.6 as ‘Not applicable’]
If you believe that the research activities outlined meet one or more of the criteria outlined in “HRP-
312- Worksheet- Exemption Determination”, check the following box in addition to a consent checkbox 
above.
 Exempt Research - By checking this box, you are verifying that the consent process will disclose the 
following:
•
For all 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; permission for use of data can 
be withdrawn for research activities involving the collection and use of identifiable data.  
•
For research that uses student educational records: the records that may be used; the purpose 
of using those records; the party or class of parties to whom the records may be shared; and 
that if an adult student (or a parent of a student who is not an adult) requests, the school will 
provide them with a copy of the records shared. Additionally, the parent or adult student will 
sign and date the consent.  
Note: If this box has been checked, mark Sections 5.3, 5.4, 5.5, and 5.6 as “Not applicable.” If the 
investigator’s assessment is inaccurate, an IRB Analyst will request revision to the protocol and ask 
that consent forms and recruitment materials be submitted. Except for exemptions where Limited 
IRB Review is required (see “HRP-312- Worksheet- Exemption Determination”) or where 
otherwise requested by the IRB, consent forms and recruitment materials are generally not 
reviewed nor approved by the PSU HRPP for research undergoing exempt review. 
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5.2
Obtaining Informed Consent 
5.2.1
Consent Process 
Describe the consent process (when, where, and how), including how subjects are provided 
the consent language and how subjects indicate consent. Describe the HIPAA authorization 
process (if applicable), making sure to state if authorization occurs during the consent process 
or describe a standalone authorization process.
If there are multiple consent processes, describe each process separately.
Consent for screening procedures will be obtained prior to the telephone screening call via 
REDCap (see attachments canned email to individuals eligible for a telephone screening; HRP-
585 Screening Consent Form). The research team member conducting the telephone screening 
will be in a private room.
Written informed consent will be obtained at the first clinic appointment (screening visit) before 
any data collection procedures are conducted. The consent process will be conducted at the 
Clinical Research Center, Noll Laboratory in a private room. Written informed consent (see 
attachment HRP-580 Written Consent Form) will be obtained through physical signature on the 
paper form and/or through e-signatures via the CTSI-developed REDCap e-consent. E-Consent 
will be obtained using REDCap econsent, the REDCap project was created using the CTSI REDCap 
eConsent Guidance Version 02/28/2025.
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.
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 visit is scheduled, and will 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. Once the participant indicates they are ready, they will be asked to sign the consent 
form.
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
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  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.) 
For distinct cultural groups, 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, or implied consent form)
The Attachment HRP 585 Screening Consent will be administered via REDCap to obtain consent 
prior to the telephone screening.
5.4
Alteration of consent: 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
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
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5.4.5
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not 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
Waiver of consent: Informed consent will not be obtained 
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
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 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.
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.
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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. We do not have 
resources allocated to the enrollment of non-English speaking subject (e.g., translation of study 
materials to other languages).  
5.6.2
Adults with Impaired Decision-Making Capacity
Refer to “HRP-417 -CHECKLIST- Adults with Impaired Decision-Making Capacity” for information 
about research involving adults with impaired decision-making capacity. 
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.
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.
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Not applicable
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.”
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.  
[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]
Signed authorization will be obtained and documented. [If this is the only box checked, mark 
sections 6.2 and 6.3 as not applicable]
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Partial waiver for recruitment purposes only (e.g. 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 for entire research study (e.g., medical record review studies). [Complete all parts 
of sections 6.2 and 6.3]
Alteration to waive requirement for written documentation of authorization (e.g. verbal or 
implied authorization). [Complete all parts of sections 6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
This section is about the disclosure of PHI as it relates to the requested authorization waiver and/or 
alteration. Complete each item in this section in relation to each requested waiver of authorization 
and/or alteration (the last three boxes in Item #6.1).  For example, if requesting a partial waiver for 
recruitment, these items need to address the PHI for recruitment rather than addressing the use of PHI 
for the entire study.
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 
If the research does not involve a waiver or alteration of authorization, 
remove the statement and indicate as not applicable. 
Not applicable
6.2.1.2
Plan to destroy identifiers or a justification for retaining identifiers 
Describe the plan to destroy the identifiers (associated with the waiver 
and/or alteration of authorization) at the earliest opportunity consistent 
with the conduct of the research. Include when and how identifiers will be 
destroyed. 
If identifiers are to 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 reasons why the research or the portion of the research could not be conducted 
without access to and use of PHI (for which the study team is requesting the waiver and/or 
related to the alteration of authorization).
Not applicable
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6.2.3
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
Provide reasons why the research or the portion of the research could not be conducted 
without a signed authorization from the subjects.  If more than one waiver and/or alteration of 
authorization (e.g. waiver for recruitment and alteration for verbal authorization) is requested, 
make sure to provide reasoning for each request.
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. 
If the research does not involve a waiver or alteration of authorization, 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. 
This is a two-arm randomized parallel study. Participants will be randomized to one of the following 
attention and resource matched conditions for 16 weeks ± 7 days: 1) education to consume 1.5 oz./day 
of pecans in place of the snacks they usually eat that are higher in saturated fat and/or added sugars; 2) 
continue consuming their current diet with provision gift cards worth $15 monthly (equivalent value to 
the pecans) and matched contact with study personnel.
Assessment of outcomes will occur at baseline and the end of the intervention period (week 16 ± 7 
days). At the baseline and 16 weeks, two blood samples will be collected (separated by approximately 
24 hours) for endpoint analysis. Weight will be measured on both days at each time point. Central and 
peripheral blood pressure and pulse wave velocity will be measured on one day at each time point. 
Dietary intake will be assessed prior to baseline and during week 16 using 24-hour recalls. Participants 
will also provide a fecal collection at baseline and 16 weeks. Participants will also wear a continuous 
glucose monitor for 7 days prior to the first study visit and for 7 days during their last week of the study 
(week 16 ± 7 days). 
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.) For surveys, 
indicate if subjects are able to skip questions that they don’t want to answer.
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•
WHERE: (e.g., classrooms, labs, internet/online, places of business, medical settings, public spaces, 
etc.)
7.2.1
Visit 1 – Screening 
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 delete 7.2.2. 
The clinic screening appointment will be held at the Penn State Clinical Research Center (CRC). 
Participants will fast for 12 hours prior to the visit and avoid over-the-counter medications and 
alcohol for 48 hours. Participants will receive a confirmation email and an email about the 
appointment (See attachments Clinic Screening Appointment Reminder). At the clinic screening 
(see attachment Screening Data Collection Form), written informed consent will be obtained 
before any screening activities are conducted. The consent process will take place in a private 
room with the door shut. Prior to the clinic screening appointment, participants will be sent a 
Medical History Form (see Attachment Medical History Form) to complete via REDCap. If they do 
not complete it prior to the screening visit, it will be completed at the screening visit via REDCap 
or using a paper form. 
The study coordinator will then measure body weight to the nearest 100 g with a calibrated 
electronic scale while the participant is wearing light clothing without shoes. Height will be 
measured using a stadiometer to the nearest 0.5 cm. Blood pressure will be measured with an 
automated machine. The measurement will be performed in the seated position after a 5-
minute rest period using an appropriately sized cuff placed on the left arm (unless there is a 
reason that prevents this, e.g., participant reports pain or discomfort in the left arm and 
requests the right arm be used). Three measurements will be taken with a one-minute break 
between each measurement while no staff are in the room. An average of the last two 
measurements will be used for screening blood pressure. Females of childbearing potential will 
provide a urine sample for pregnancy testing. If, after these measurements it is determined that 
the participant is still eligible, a CRC nurse will take the blood draw (approximately 12.5 mL of 
blood or ~1 tablespoons will be taken). Blood samples will be sent to Quest Diagnostics to 
perform the following blood tests: complete blood count (CBC), comprehensive metabolic panel, 
iron, phosphate, lipid panel, uric acid, and HbA1c. 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. No blood 
taken at this visit will be stored for future use. 
Participants will be contacted within one week 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 the person’s eligibility. There will be no charge for the screening blood work or 
measurements, and participants will receive the results of their screening blood work.
If all eligibility criteria are met, participants will be called to inform them and discuss their study 
schedule. Once the schedule is agreed upon, participants will be sent an email (see attachment 
Canned Email_Participant Schedule) that includes their schedule as an attachment (see 
attachment Participant Schedule Template). Baseline visits will typically occur within 1 month of 
the screening appointment. If a participant’s baseline visit is not scheduled within 3 months, the 
screening visit must be performed again.
  
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7.2.2
Visit 2 – CGM fitting
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.). If your study involves only 
one session or visit, delete this section.
This visit will be conducted approximately 7 days prior to visit 3 at the Penn State CRC. The visit 
will take approximately 15 minutes and will be conducted according to Data Collection 
Form_Visit 2 (see attachment). Participants will not be asked to complete any pre-visit 
procedures (e.g., fasting). The visit will be scheduled in the morning at approximately the same 
time as their baseline and endpoint testing visits. Participants will receive a reminder email at 
least 48 hours prior to the appointment (see attachment Canned Email_Visit 2 Appointment 
Reminder).
Participants will be asked to review their medical history form (see attachment Medical History 
Form) administered via REDCap 3 days prior to the study visit to update any changes to 
medications and/or health status that may affect study outcomes. Study staff will review changes 
to medications and/or health status with the Principal Investigator. According to PI discretion 
upon review of the updated medical history form, participants who are eligible to continue in the 
study will proceed with the testing visit, but participants will be withdrawn from the study if they 
have been diagnosed with a disease listed as an exclusion criterion or a serious medical condition 
requiring active intervention and/or medications that may affect study outcomes. 
At this visit, a trained research staff member or a CRC nurse will fit the participant with an Abbott 
FreeStyle Libre Pro continuous glucose monitor (CGM) sensor (see attachment CGM Operator’s 
Manual) according to the manufacturer’s instructions (see attachment CGM Fitting Instructions). 
Hair may need to be shaved from the participant's arm if present, because this affects the 
adhesion of the sensor. The participants will be asked to wear the CGM until they return for visit 
3. The sensor measures interstitial glucose concentrations every 15 minutes during wear. The 
sensor does not show the glucose value, so participants will be unaware of their values. These 
data will be used to calculate metrics of glucose control, e.g., mean glucose, mean time in tight 
range (70 and 140 mg/dL), and glycemic variability assessed by the coefficient of variability.
Participants will be asked to avoid taking vitamin C supplements or supplements containing 
vitamin C during the time they are wearing the sensor because vitamin C affects the sensor 
readings. In addition, participants will be asked to avoid taking salicylic acid (found in some pain 
relievers such as aspirin) because this affects the sensor readings (see attachment CGM 
participant information sheet).  
At visit 3, a staff member will remove the sensor.
During the approximately 7-day period they are wearing the sensor, participants will be asked to 
take 12 saliva samples at home over two days by spitting into collection containers (e.g., passive 
drool method). On each day, participants will be asked to take six samples. These samples will be 
used to assess cortisol levels (an exploratory outcome) throughout the day as a marker of 
physiological stress. These samples are being completed because physiological stress is known to 
impact heart and metabolic health and will be used to examine inter-individual variability in 
response to the intervention. Participants will be provided with a sample collection kit and 
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detailed instructions (See Saliva Collection Instructions) for sample collection at home. 
Participants will return their samples at visit 3. 
During the approximately 7-day period they are wearing the sensor, participants will be asked to 
complete three 24-hour recalls to estimate their usual dietary intake. Participants will receive an 
email following Visit Two with instructions and log in information for completing three 24-hour 
dietary recalls (see attachments Canned Email_ASA24 Instructions.docx; ASA24-
DietAssessmentInstructionSheet.docx). Participants who do not complete the recalls during the 7 
days period will be asked to complete one recall at visit 3 and one recall at visit 4. A reminder to 
complete the recalls will be included in the Visit 3 appointment reminder email (See attachment 
Canned Email_Baseline_Endpoint Appointment Reminder).  
The Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool will be used to 
administer the 24-hour recalls. 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 2020, intake of added sugars 
and saturated fats, as well as nutrient intake.
Prior to visit 3, participants will be asked to complete surveys about their physical activity 
(International Physical Activity Questionnaire; see attachment IPAQ), sleep health (see 
attachment Pittsburgh Sleep Quality Index Survey), stress (see attachments Perceived Stress 
Scale Survey, Psychological Well-being Scale, Life Events Checklist), loneliness (see attachment 
UCLA Loneliness Scale), and depression and anxiety symptoms (see attachment PHQ-8 and GAD-
7). A link to the surveys will be emailed to the participant via a secure REDCap link 3 days prior to 
the baseline day 1 testing visit (see attachment Canned Email_Baseline Appointment Reminder). 
If participants do not complete these surveys prior to baseline day 1 testing, they will be asked to 
complete them during the baseline testing day 1 visit. These surveys are being completed 
because these factors are known to impact heart and metabolic health and will be used to 
examine inter-individual variability in response to the intervention. The sleep health survey is 
designed to assess the participants’ usual sleep habits. The perceived stress survey, life events 
checklist, psychological well-being survey, and loneliness survey are designed to assess exposure 
to psychological stress. The sleep health, stress, well-being, loneliness, and depression and 
anxiety surveys are not diagnostic instruments for any psychological distress, and therefore pose 
no risk to participants, and no action is needed for safety based on responses. 
7.2.3
Visit 3 – Baseline Day 1 Testing 
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.). If your study involves only 
one session or visit, delete this section.
The visit will be conducted according to the Baseline Data Collection Form (see attachment); a 
paper form will be completed, or the staff member will directly enter the data into REDCap. 
Participants will be asked to fast for 12 hours (except drink plenty of water), avoid over-the-
counter medications and alcohol for 48 hours prior to the visit, and avoid vaccinations, including 
the flu shot within 2 weeks of the visit. The visit will be conducted at the Penn State CRC. 
The CGM sensor will be removed.
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If participants have not yet completed the surveys about sleep health (see attachment 
Pittsburgh Sleep Quality Index_Survey), stress (see attachment Perceived Stress Scale_Survey, 
Psychological Well-Being Scale, Life Events Checklist), physical activity (see attachment IPAQ), 
loneliness (see attachment Loneliness Scale), and depression and anxiety symptoms (see 
attachment PHQ8 and GAD7) they will be asked to complete them during this visit via REDCap or 
paper form. If participants have not completed all of their 24-dietary recalls, they will be asked 
to complete a recall during this visit. 
Body weight will be measured, pulse wave analysis (PWA) will be performed to assess central 
and peripheral blood pressure, pulse wave velocity (PWV) will be measured, a blood draw and a 
hair sample will be taken. Participants will be given a fecal collection kit and asked to collect a 
sample at home and bring it to the Day 2 visit. If participants are not able to complete a fecal 
collection between their Day 1 and Day 2 visit, they may be provided with the kit and asked to 
do the collection the weekend prior to their visit. Females of childbearing potential will provide 
a urine sample for pregnancy testing. Saliva samples will be returned by the participant. 
Pulse Wave Analysis (PWA)
To ensure accurate and reliable readings, participants will be asked to wear a light or short-
sleeved top/shirt to their visit. Following a 5-minute seated rest period, brachial artery systolic 
and diastolic blood pressure will be measured using the left arm, unless there is a reason that 
prevents this (e.g., participant reports pain or discomfort in the left arm and requests the right 
arm be used), 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). Three measurements will be taken with 
a one-minute break between each measurement. An average of the last two measurements will 
be used for data analysis. If brachial systolic blood pressure is inconsistent (i.e., >10 mm Hg 
difference), a fourth measurement will be taken, and the 2 closest measurements from 
measurements 2-4 will be used for analysis.
Pulse Wave Velocity (PWV)
Carotid-Femoral PWV will be measured using the SphygmoCor ECEL device (AtCor Medical, 
Sydney, Australia). To ensure accurate and reliable readings, participants will be requested to 
wear shorts or pants made of thin material (e.g., tights) to their visit. If participants forget to 
wear or bring this type of clothing, the study team will provide them with shorts to wear during 
the measurements. A blood pressure 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. The measurement will be 
performed in the supine position immediately following the PWA measurement. Three 
measurements will be taken. If the measurements are inconsistent (i.e.,> 0.5 m/s difference), a 
fourth measurement will be taken. The three closest measurements will be averaged for data 
analysis.
Plasma/serum analysis
Approximately 45 mL (about 3 tbsp) will be collected at each visit. A typical American Red Cross 
blood donation is 1 pint (500 mL). Plasma/serum will be aliquoted (~0.5-1mL per aliquot) and 
stored at −80°C. At the end of the study (i.e. once all participants are done), frozen aliquots of 
serum/plasma will be shipped to a commercial laboratory (e.g. LabCorp and Quest Diagnostics) 
or taken to a laboratory on the Penn State campus (e.g. Biomarker Core Laboratory) for analysis 
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of the following: blood lipids and lipoprotein concentration, particle number and size, glucose 
and insulin, other markers of glycemia, heart disease risk, cholesterol metabolism, and/or 
inflammation. Remaining aliquots will be stored for future use.
Fecal collection
Participants will be asked to collect a stool sample (~50 g). They will be provided with a stool 
sample kit and detailed instructions (see attachment Fecal Collection Instructions) for the 
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 to collect the sample within this timeframe, alternative 
arrangements will be made to accommodate the subject. Samples will be frozen at −80°C until 
the completion of the study. At the end of the study, frozen fecal samples will be analyzed for 
gut bacteria composition (gut microbiome) by a laboratory that specializes in these analyses 
(laboratory TBD). Following the analysis, the remainder of the sample will be refrozen and 
stored for future use.
Hair sample 
A hair sample of approximately 10-20 strands of hair will be collected to assess cortisol as a 
biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity to assess chronic stress 
exposure. This sample is being completed because chronic stress is known to impact heart and 
metabolic health and will be used to examine inter-individual variability in response to the 
intervention. The sample will be collected from the posterior vertex of the scalp (e.g., the 
highest point of the back of the head). To collect the sample, a trained research staff member 
will use scissors to cut a small section of hair that is approximately the width of a pencil tip as 
close to the scalp as possible. Hair testing will be done by the Penn State Biomarker Core Lab. 
Participants can withdraw consent for the hair collection at any time without any effect on 
participation in other parts of the study.
7.2.4
Visit 4 – Baseline Day 2 Testing 
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.). If your study involves only 
one session or visit, delete this section.
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 PWA and PWV measurements will be taken 
if they were not completed on Day 1 for any reason. Body weight will be taken. Fecal sample 
collection will be brought to the visit by the subject. If participants have not completed all of 
their 24-dietary recalls, they will be asked to complete a recall during this visit.
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, glucose and insulin, other markers of glycemia, heart disease risk, cholesterol 
metabolism, and/or inflammation. Remaining aliquots will be stored for future use. 
Following completion of this visit. Participants will go to the Penn State Research Kitchen in 224 
Henderson for randomization. Participants will be provided with a map and directions to the 
Research Kitchen (See attachment Research Kitchen Directions and Parking). Participants will be 
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informed of which study group they are in. Depending on the group, the participants will be 
provided with either the “Usual Diet Group Instructions” or “Pecan Group Instructions” and the 
information sheet will be explained. Participants in the pecan group will receive a month’s 
supply of pre-portioned pecans. The control group will receive a $15 gift card. Each month, 
participants in both groups will go to the Penn State Research Kitchen for the collection of 
pecans or a gift card, depending on which group they are in. Participants will also receive daily 
adherence tracking surveys through SMS text messaging through REDCap (see attached “Daily 
monitoring text message pecan condition” or “Daily monitoring text message usual diet 
condition”). Participants can opt out of text messaging at any time. If participants opt out, they 
will complete a paper daily monitoring form (see attached “Paper Daily Monitoring Form Pecan 
condition” and “Paper Daily Monitoring Form Usual Diet Condition”)
7.2.5
Visit 5 – CGM fitting week 15 ± 7 days
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.). If your study involves only 
one session or visit, delete this section.
This visit will be conducted approximately 7 days prior to visit 6 at the Penn State CRC. The visit 
will take approximately 15 minutes and will be conducted according to Data Collection 
Form_Visit 5. Participants will not be asked to complete any pre-visit procedures (e.g., fasting). 
The visit will be scheduled in the morning at approximately the same time as their baseline and 
endpoint testing visits. Participants will receive a reminder email at least 48 hours prior to the 
appointment (see attachment Canned Email_Visit 5 Appointment Reminder).
At this visit, a trained research staff member or a CRC nurse will fit the participant with an Abbott 
FreeStyle Libre Pro continuous glucose monitor (CGM) sensor (see attachment CGM Operator’s 
Manual) according to the manufacturer’s instructions (see attachment CGM Fitting Instructions). 
Hair may need to be shaved from the participant's arm if present, because this affects the 
adhesion of the sensor. The participants will be asked to wear the CGM until they return for visit 
3. The sensor measures interstitial glucose concentrations every 15 minutes during wear. The 
sensor does not show the glucose value, so participants will be unaware of their values. These 
data will be used to calculate metrics of glucose control, e.g., mean glucose, mean time in tight 
range (70 and 140 mg/dL), and glycemic variability assessed by the coefficient of variability.
Participants will be asked to avoid taking vitamin C supplements or supplements containing 
vitamin C during the time they are wearing the sensor because vitamin C affects the sensor 
readings. In addition, participants will be asked to avoid taking salicylic acid (found in some pain 
relievers such as aspirin) because this affects the sensor readings (see attachment CGM 
participant information sheet).  
At visit 6, a staff member will remove the sensor.
Participants will be asked to take 12 saliva samples at home over two days by spitting into 
collection containers (e.g., passive drool method) during their last week in the study. On each 
day, participants will be asked to take six samples. These samples will be used to assess cortisol 
levels throughout the day as a marker of physiological stress. These samples are being completed 
because physiological stress is known to impact heart and metabolic health and will be used to 
examine inter-individual variability in response to the intervention. Participants will be provided 
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with a sample collection kit and detailed instructions (See Saliva Collection Instructions) for 
sample collection at home. Participants will return their samples at visit 6.
Participants will be asked to complete three 24-hour recalls during their last week in the study. 
The Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool will be used to 
administer the 24-hour recalls. 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 the calculation of diet quality assessed by the Healthy Eating Index 2020, intake of added 
sugars and saturated fats, as well as nutrient intake. Participants will receive an email following 
Visit 5 with instructions and log in information for completing three 24-hour dietary recalls (see 
attachments Canned Email_ASA24 Instructions.docx; ASA24-
DietAssessmentInstructionSheet.docx). Participants in the pecan group will receive an additional 
instruction sheet for how to report pecan intake (see attachment ASA24-
DietAssessmentInstructionSheet Pecan). Participants who do not complete the recalls during the 
7 days period will be asked to complete one recall at visit 6 and one recall at visit 7. A reminder to 
complete the recalls will be included in the Visit 6 appointment reminder email (See attachment 
Canned Email_Baseline_Endpoint Appointment Reminder).  
Participants will be asked to complete surveys about their physical activity (International Physical 
Activity Questionnaire; see attachment IPAQ), sleep health (see attachment Pittsburgh Sleep 
Quality Index Survey), stress (see attachments Perceived Stress Scale Survey, Psychological Well-
being Scale, Life Events Checklist), loneliness (see attachment UCLA Loneliness Scale), and 
depression and anxiety symptoms (see attachment PHQ-8 and GAD-7). A link to the surveys will 
be emailed to the participant via a secure REDCap link 3 days prior to the baseline day 1 testing 
visit (see attachment Canned Email_Baseline_Endpoint Appointment Reminder). These surveys 
will be completed so that changes in physical activity, sleep health, and stress can be captured 
because these factors are known to impact heart and metabolic health. This will provide 
preliminary data for future investigations. If participants do not complete these surveys prior to 
endpoint day 1 testing, they will be asked to complete them during the endpoint testing day 1 
visit.
7.2.6
Visit 6 – Endpoint Day 1 Testing 
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.). If your study involves only 
one session or visit, delete this section.
The visit will be conducted according to the Data Collection Form_ Endpoint Day 1 (see 
attachment); a paper form will be completed, or the staff member will directly enter the data 
into REDCap. Participants will be asked to fast for 12 hours (except drink plenty of water), avoid 
over-the-counter medications and alcohol for 48 hours prior to the visit, and avoid vaccinations, 
including the flu shot within 2 weeks of the visit. The visit will be conducted at the Penn State 
CRC. 
If participants have not yet reviewed their Medical History Form or completed the survey about 
sleep health (see attachment Pittsburgh Sleep Quality Index_Survey), stress (see attachment 
Perceived Stress Scale_Survey, Psychological Well-Being Scale, Life Events Checklist), physical 
activity (see attachment IPAQ), loneliness (see attachment Loneliness Scale), and depression 
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and anxiety symptoms (see attachment PHQ8 and GAD7) they will be asked to complete them 
during this visit via REDCap or paper form. If participants have completed <3 24-dietary recalls, 
they will be asked to complete a recall during this visit.
The CGM will be removed. Body weight will be measured, pulse wave analysis (PWA) will be 
performed to assess central and peripheral blood pressure, pulse wave velocity (PWV) will be 
measured, and a blood draw will be taken. Participants will be given a fecal collection kit and 
asked to collect a sample at home and bring it to the Day 2 visit. If participants are not able to 
complete a fecal collection between their Day 1 and Day 2 visit, they may be provided with the 
kit and asked to do the collection the weekend prior to their visit. Females of childbearing 
potential will provide a urine sample for pregnancy testing. Participants will return their saliva 
samples. 
Pulse Wave Analysis (PWA)
To ensure accurate and reliable readings, participants will be asked to wear a light or short-
sleeved top/shirt to their visit. Following a 5-minute seated rest period, brachial artery systolic 
and diastolic blood pressure will be measured using the left arm, unless there is a reason that 
prevents this (e.g., participant reports pain or discomfort in the left arm and requests the right 
arm be used), 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). Three measurements will be taken with 
a one-minute break between each measurement. An average of the last two measurements will 
be used for data analysis. If brachial systolic blood pressure is inconsistent (i.e., >10 mm Hg 
difference), a fourth measurement will be taken, and the 2 closest measurements from 
measurements 2-4 will be used for analysis.
Pulse Wave Velocity (PWV)
Carotid-Femoral PWV will be measured using the SphygmoCor ECEL device (AtCor Medical, 
Sydney, Australia). To ensure accurate and reliable readings, participants will be requested to 
wear shorts or pants made of thin material (e.g., tights) to their visit. If participants forget to 
wear or bring this type of clothing, the study team will provide them with shorts to wear during 
the measurements. A blood pressure 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. The measurement will be 
performed in the supine position immediately following the PWA measurement. Three 
measurements will be taken. If the measurements are inconsistent (i.e.,> 0.5 m/s difference), a 
fourth measurement will be taken. The three closest measurements will be averaged for data 
analysis.
Plasma/serum analysis
Approximately 45 mL (about 3 tbsp) will be collected at each visit. A typical American Red Cross 
blood donation is 1 pint (500 mL). Plasma/serum will be aliquoted (~0.5-1mL per aliquot) and 
stored at −80°C. At the end of the study (i.e. once all participants are done), frozen aliquots of 
serum/plasma will be shipped to a commercial laboratory (e.g. LabCorp and Quest Diagnostics) 
or taken to a laboratory on the Penn State campus (e.g. Biomarker Core Laboratory) for analysis 
of the following: blood lipids and lipoprotein concentration, particle number and size, glucose 
and insulin, other markers of glycemia, heart disease risk, cholesterol metabolism, and/or 
inflammation. Remaining aliquots will be stored for future use.
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Fecal collection
Participants will be asked to collect a stool sample (~50 g). They will be provided with a stool 
sample kit and detailed instructions (see attachment Fecal Collection Instructions) for the 
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 to collect the sample within this timeframe, alternative 
arrangements will be made to accommodate the subject. Samples will be frozen at −80°C until 
the completion of the study. At the end of the study, frozen fecal samples will be analyzed for 
gut bacteria composition (gut microbiome) by a laboratory that specializes in these analyses 
(laboratory TBD). Following the analysis, the remainder of the sample will be refrozen and 
stored for future use.
Hair sample 
A hair sample of approximately 10-20 strands of hair will be collected to assess cortisol as a 
biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity to assess chronic stress 
exposure. This sample is being completed because chronic stress is known to impact heart and 
metabolic health and will be used to examine inter-individual variability in response to the 
intervention. The sample will be collected from the posterior vertex of the scalp (e.g., the 
highest point of the back of the head). To collect the sample, a trained research staff member 
will use scissors to cut a small section of hair that is approximately the width of a pencil tip as 
close to the scalp as possible. Hair testing will be done by the Penn State Biomarker Core Lab. 
Participants can withdraw consent for the hair collection at any time without any effect on 
participation in other parts of the study.
7.2.7
Visit 7 – Endpoint Day 2 Testing 
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.). If your study involves only 
one session or visit, delete this section.
On day 2 of the endpoint visit, which occurs approximately 24 hours after day 1 testing, a fasting 
blood sample will be collected, and PWA and PWV measurements will be taken if they were not 
completed on Day 1 for any reason. Body weight will be taken. Fecal sample collection will be 
brought to the visit by the subject. If participants have not completed all of the required 24 hour 
recalls they will be asked to complete a recall during this visit. 
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, glucose and insulin, other markers of glycemia, heart disease risk, cholesterol 
metabolism, and/or inflammation. Remaining aliquots will be stored for future use. 
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.  
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Each participant will be in the study for up to 7 months. The study is 4 months, and it may take up to 3 
months before an eligible person is scheduled for their baseline visit. The screening visit will take 
approximately 1 hour, and the CGM fitting appointments will take approximately 15 minutes. The 
testing visits will take approximately 1 hour on day 1 and approximately 45 minutes on day 2. The 
screening visit, CGM visits, and 4 testing visits (7 visits total) will take approximately 5 hours total.
Monthly appointment for pecans/gift cards and adherence monitoring will take approximately 15 
minutes (1 hour for 4 visits – 1 per month). Therefore, this study will involve approximately 6 hours. 
8.0
Number of Subjects and Statistical Plan
8.1
Number of Subjects
Indicate the maximum number of subjects to be accrued/enrolled, to include all persons who sign 
consent for the study. If applicable, 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 (i.e., 
numbers of subjects excluding screen failures.)
To be powered, 147 individuals need to be randomized and 128 need to complete the research 
procedures. To randomize this number, it is expected that 442 individuals will be enrolled and screened. 
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.
Sample size calculations show 128 participants (64 per group) will provide 80% power to detect a 0.08 
(SD 0.16)20 percentage point between-group difference in HbA1C (⍺=0.05). In total, 147 participants will 
be randomized to allow for an attrition rate of ~15%. 
8.3
Statistical or Analytic Methods
Describe the statistical methods (or non-statistical methods of analysis) that will be employed.
All data collected from randomly assigned participants will be included in data analyses consistent with 
intent-to-treat principles. Assumptions for all statistical tests will be checked and confirmed prior to 
conducting analyses for hypothesis testing. The primary analyses for all outcomes will assess the 
between-group (pecan or usual diet) differences in the change from baseline using linear regression. The 
change from baseline will be calculated by subtracting the endpoint value from the baseline value. 
Secondary analyses will be conducted to assess the between-group differences in endpoint means for all 
outcomes using linear mixed models. This will be done to confirm the primary analyses. Group will be 
included as a fixed effect, and visit will be included as a repeated effect. Intervention effects will be 
determined by examining the group-by-visit interaction. When significant group-by-visit interaction is 
detected, post hoc testing will be conducted, and the Tukey-Kramer method will be used to adjust for 
multiple comparisons.
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.”
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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 each section below if the research involves more than minimal risk to subjects or indicate not 
applicable. If reviewed at a convened board, the board may require the completion of this section.  Note: For 
cancer-related trials, PRC will ask for data safety monitoring for low-risk trials outside of the IRB process.   
[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
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.
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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 and must be listed here.
•
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 the 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 screening; however, it is possible that 
an unknown pecan allergy may manifest during the study. This is most likely to occur within the first week of the 
study. Each day participants will be asked to complete a daily monitoring form. In addition, we ask participants 
to please inform study staff immediately should any adverse events occur. 
Food Preparation
Pecans will be purchased from local stores or food delivery services and pre-portioned into 1.5 oz. servings by 
kitchen staff according 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. 
Fasting:
After a 12-hour overnight fast (except drinking plenty of water), participants may feel slightly faint or dizzy. This 
risk will be minimized as participants will be reminded to drink water the morning of the blood draw and will be 
provided with a snack after all testing required for the study visit is completed.
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 medical 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. The medical staff will ask that 
the participant remains at the clinic until their blood pressure has been checked and they are cleared from any 
further risk.
Pulse Wave Analysis (PWA) and Pulse Wave Velocity 
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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.
Stool Collection
Participants may experience some level of embarrassment or discomfort from being asked to collect stool 
samples. However, participants will be provided with detailed instructions on how to collect the samples within 
the comfort of their own home, and at their convenience, to help reduce concerns.
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.
Continuous glucose monitoring
Skin irritation or allergic reactions may occur at the sensor site. There is also a slight chance of infection, this risk 
will be minimized and most likely eliminated by having trained staff fit the sensor. 
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.
Participants will receive their screening laboratory results, complete blood count (CBC), comprehensive 
metabolic panel, iron, phosphate, lipid panel, uric acid, and HbA1c, at no cost.
11.2
Potential Benefits to Others
Describe the potential benefits to society or others. 
The results will contribute to understanding the role of snacking in cardiometabolic health. These results 
may inform guidelines e.g., the Dietary Guidelines for Americans that would benefit the U.S. population. 
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 and will be sent to their mailing address via postal delivery. All screening 
results will be reviewed by the Nurse Practitioner or Physician at the Clinical Research Center. Should any 
abnormal lab values be identified that warrant further evaluation, the individual will be contacted (by the Study 
Coordinator or the CRC Nurse Practitioner, or the Physician) and asked to schedule a visit with their primary care 
physician. 
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At the completion of the study, the key findings from the study overall may be posted on our laboratory’s 
website. Upon request, individual results may be given to participants at the completion of all study-related data 
collection and analyses. Study results will not be provided to participants during the study because knowledge of 
the results may change behavior and influence the study results. 
13.0
Subject Payment and/or Travel Reimbursements
Describe the amount, type (cash, check, gift card, other), reason/purpose (travel reimbursement or 
compensation for their time, inconvenience, discomfort), 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. 
Participants will be paid up to $150 as compensation for the time and burden associated with participating in 
the study. Payment will be made following completion of the endpoint day 2 testing. Payment will be prorated 
as follows for partial completion. 
Participation in baseline day 1 and day 2 testing = $30
Participation in endpoint day 1 and day 2 testing = $120
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.
Participants are responsible for their own transportation to the Clinical Research Center for study visits 
and to the Penn State Research Kitchen. At the Clinical Research Center and the Metabolic Kitchen, free 
parking is available.
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:
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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 the 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 the research protocol. The principal 
investigators and project coordinators are experienced with conducting research at this location and 
have conducted multiple clinical trials at this location previously.
The Penn State Research Kitchen
This is a state-of-the-art facility consisting of 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.
We have previously done studies of this nature and have not had difficulty recruiting. We use several 
different recruitment methods and have budgeted sufficient resources for advertising. Additionally, we 
have access to a large database of previous participants who have consented to further contact.
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. Consider outside responsibilities as well as other ongoing research for which 
the PI is responsible. Please only provide a response for the principal investigator – do not include 
information about any other study team members.
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The Principal Investigator will be responsible for assuring through personal contact with the research 
and clinical staff and coordinators that each individual clearly understands and accepts the obligations 
incurred in the undertaking of this clinical trial.
The Principal Investigator will ensure that the research 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; 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.
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.
Nursing staff are always present during clinical testing. Highly trained nursing staff will perform 
procedures requiring licensure or demonstrated competency e.g., blood pressure, blood draws. A 
physician or CRNP will review all screening visit results as part of the eligibility assessment of a 
participant. 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.
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.
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 Ancillary Reviews
DO NOT ALTER OR DELETE: 
Ancillary reviews are reviewed by other compliance groups or individuals within Penn State that inform 
the IRB’s review of a new study or a modification to an existing study.
PSU IRB may set applicable ancillary reviews for your study. Please refer to the “HRP-309 Worksheet – 
Ancillary Review Matrix” for more information (found in the CATS Library).
[Do not type here]
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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.
Not applicable
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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
References
List relevant references in the literature which highlight methods, controversies, and study outcomes.
1. 
U.S. Centers for Disease Control and Prevention. National Diabetes Statistics Report. Published 2024. Accessed December 18, 
2024. https://www.cdc.gov/diabetes/php/data-research/index.html
2. 
American Diabetes Association Professional Practice Committee. 3. Prevention or Delay of Diabetes and Associated 
Comorbidities: Standards of Care in Diabetes—2025. Diabetes Care. 2024;48(Supplement_1):S50-S58.
3. 
Ligthart S, van Herpt TTW, Leening MJG, et al. Lifetime risk of developing impaired glucose metabolism and eventual 
progression from prediabetes to type 2 diabetes: a prospective cohort study. Lancet Diabetes Endocrinol. 2016;4(1):44-51.
4. 
Evert AB, Dennison M, Gardner CD, et al. Nutrition therapy for adults with diabetes or prediabetes: a consensus report. 
Diabetes Care. 2019;42(5):731.
5. 
2025 Dietary Guidelines Advisory Committee. Scientific Report of the 2025 Dietary Guidelines Advisory Committee: 
Advisory Report to the Secretary of Health and Human Services and Secretary of Agriculture.; 2024. Accessed December 15, 
2024. https://doi.org/10.52570/DGAC2025
6. 
Enriquez JP, Gollub E. Snacking consumption among adults in the United States: a scoping review. Nutrients. 
2023;15(7):1596.
7. 
Cooke CB, Greatwood HC, McCullough D, et al. The effect of discretionary snack consumption on overall energy intake, 
weight status, and diet quality: A systematic review. Obesity Reviews. 2024;25(4):e13693.
8. 
Barnes TL, French SA, Harnack LJ, Mitchell NR, Wolfson J. Snacking behaviors, diet quality, and body mass index in a 
community sample of working adults. J Acad Nutr Diet. 2015;115(7):1117-1123.
9. 
U.S. Department of Agriculture, U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020-
2025. 9th Edition. Published 2020. Accessed January 1, 2021. www.dietaryguidelines.gov
10. 
Lichtenstein AH, Appel LJ, Vadiveloo M, et al. 2021 Dietary Guidance to Improve Cardiovascular Health: A Scientific 
Statement From the American Heart Association. Circulation. 2021;23(144):e472-487.
11. 
Becerra-Tomás N, Paz-Graniel I, WC Kendall C, et al. Nut consumption and incidence of cardiovascular diseases and 
cardiovascular disease mortality: a meta-analysis of prospective cohort studies. Nutr Rev. 2019;77(10):691-709.
12. 
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. American Journal of 
Clinical Nutrition. 2015;102(6):1347-1356. doi:10.3945/ajcn.115.110965
13. 
Nishi SK, Paz-Graniel I, Ni J, et al. Effect of nut consumption on blood lipids: An updated systematic review and meta-
analysis of randomized controlled trials. Nutrition, Metabolism and Cardiovascular Diseases. 2025;35(5):103771. 
doi:https://doi.org/10.1016/j.numecd.2024.10.009
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14. 
Tindall AM, Johnston EA, Kris-Etherton PM, Petersen KS. The effect of nuts on markers of glycemic control: A systematic 
review and meta-analysis of randomized controlled trials. American Journal of Clinical Nutrition. 2019;109(2).
15. 
Viguiliouk E, Kendall CWC, Mejia SB, et al. Effect of tree nuts on glycemic control in diabetes: A systematic review and 
meta-analysis of randomized controlled dietary trials. PLoS One. 2014;9(7):e103376. doi:10.1371/journal.pone.0103376
16. 
Rajaram S, Myint T, Sabaté J, Burke K, Connell B. A monounsaturated fatty acid–rich pecan-enriched diet favorably alters the 
serum lipid profile of healthy men and women. J Nutr. 2001;131(9):2275-2279.
17. 
Morgan WA, Clayshulte BJ. Pecans lower low density lipoprotein cholesterol in people with normal lipid levels. J Am Diet 
Assoc. 2000;100(3):312-318.
18. 
Guarneiri LL, Paton CM, Cooper JA. Pecan-enriched diets decrease postprandial lipid peroxidation and increase total 
antioxidant capacity in adults at-risk for cardiovascular disease. Nutrition Research. 2021;93:69-78.
19. 
Cogan B, Pearson RC, Paton CM, Jenkins NT, Cooper JA. Pecan-enriched diet improves cholesterol profiles and enhances 
postprandial microvascular reactivity in older adults. Nutrition Research. 2023;111:44-58.
20. 
Hart TL, Kris-Etherton PM, Petersen KS. Consuming Pecans as a Snack Improves Lipids/Lipoproteins and Diet Quality 
Compared to Usual Diet in Adults at Increased Risk for Cardiometabolic Diseases: A Randomized Controlled Trial. Am J Clin 
Nutr. Published online 2025.
21. 
Hart TL, Kris-Etherton PM, Petersen KS. Pecan Intake Improves Lipoprotein Particle Concentrations Compared with Usual 
Intake in Adults at Increased Risk of Cardiometabolic Diseases: A Randomized Controlled Trial. J Nutr. 2025;155(5):1459-
1465.
22. 
Sapp PA, Kris-Etherton PM, Petersen KS. Peanuts or an isocaloric lower fat, higher carbohydrate nighttime snack have similar 
effects on fasting glucose in adults with elevated fasting glucose concentrations: a 6-week randomized crossover trial. J Nutr. 
2022;152(1):153-162.
23. 
Riley TM, Kris-Etherton PM, Hart TL, Petersen KS. Intake of Pistachios as a Nighttime snack has similar effects on short-and 
longer-term Glycemic Control compared with education to Consume 1–2 carbohydrate exchanges in adults with prediabetes: a 
12-Wk randomized crossover trial. J Nutr. 2024;154(4):1219-1231.
24. 
Imamura F, Micha R, Wu JHY, et al. Effects of saturated fat, polyunsaturated fat, monounsaturated fat, and carbohydrate on 
glucose-insulin homeostasis: a systematic review and meta-analysis of randomised controlled feeding trials. PLoS Med. 
2016;13(7):e1002087.
25. 
Zhang X, Xiao D, Guzman G, Edirisinghe I, Burton-Freeman B. Avocado Consumption for 12 weeks and cardiometabolic 
risk factors: a randomized controlled trial in adults with overweight or obesity and insulin resistance. J Nutr. 
2022;152(8):1851-1861.
26. 
Tobias Stalder, Sonia J. Lupien, Brigitte M. Kudielka, Emma K. Adam, Jens C. Pruessner, Stefan Wüst, Samantha Dockray, 
Nina Smyth, Phil Evans, Clemens Kirschbaum, Robert Miller, Mark A. Wetherell, Johannes B. Finke, Tim Klucken, Angela 
Clow, Evaluation and update of the expert consensus guidelines for the assessment of the cortisol awakening response (CAR),
Psychoneuroendocrinology, Volume 146, 2022, 105946, ISSN 0306-4530, https://doi.org/10.1016/j.psyneuen.2022.105946.
 
21.0
Confidentiality, Privacy and Data Management 
For data level classification: https://security.psu.edu/awareness/icdt/    
For approved UP/Commonwealth storage platforms: 
https://security.psu.edu/awareness/storage/ 
https://datastoragefinder.psu.edu/computing/backup-storage/finder   
Please visit https://datastoragefinder.psu.edu and https://security.psu.edu/awareness/storage/ for 
assistance with identifying appropriate data storage options. If the software to be used does not appear on 
that site, please visit https://procurement.psu.edu/electronic-click-through-contracts to consider whether a 
software request form must be completed.
NOTE: Please refer to PSU Policy AD95 for information regarding information classification and security 
standards and requirements. UP/Commonwealth campuses: If you have questions about Penn State’s Policy 
AD95 or standards or need a consultation regarding data security, please contact Penn State IT – Information 
Security at security@psu.edu. College of Medicine: If you have questions about Penn State’s Policy AD95 or 
standards or need a consultation regarding data security, please contact Philemon Canakis in the Penn State IT 
Security Group at pcanakis@pennstatehealth.psu.edu.
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21.1
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)
 
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
21.2
Are the identifiers above linked (directly or indirectly via code list) to research data?
 No – skip to 21.3
 Yes – complete 21.2.1
21.2.1 Explain how the list that links the code to identifiers is stored, whether and how it is stored 
separately from coded data, and who has access:
When appropriate, a list/key that links indirect identifiers (code numbers, participant IDs, etc.) to direct 
identifiers should not be comingled (i.e., stored in the same location) as the identifiable data, including 
copies of signed informed consent forms. For some types of research, this may not be practical. In all 
cases, access to that list/key must be restricted to authorized project personnel.
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A master list containing a study ID number and the participant’s identity will be used. This file will be 
stored electronically in REDCap during the study and downloaded upon study completion in a secure 
PSU-approved location, e.g., OneDrive or SharePoint, where only approved study personnel will be able 
to access it through their PSU account. No study data containing study ID#'s (code numbers) will be 
stored with the master list. Upon completion of data collection, only the investigators and the study 
coordinator will have access to the list. This list will be deleted approximately 3 years after the results 
from all pre-specified primary and secondary outcomes are published.
21.3
Are paper records of research data (including copies of signed consent forms) being collected or 
stored:
 No – skip to 21.4
 Yes – complete 21.3.1 and 21.3.2
21.3.1 Where will the paper records be securely stored? 
Consent forms and paper data collection sheets will be stored in a locked filing cabinet in a 
locked office (Chandlee Laboratory) and in the Clinical Research Centre, Noll Laboratory. 
21.3.2 Will everyone on the study team have access to the stored paper records?
 Yes – skip to 21.4
 No – Explain what limitations are in place: 
Only authorized project personnel will have key access to the locked filing cabinets.
21.4
Are electronic records of research data being collected or stored?
 No – skip to 21.5
 Yes – Complete rest of 21.4
Use of one of the IT-approved solutions listed is strongly recommended. If “Other” is chosen for storage of 
identifiable data, the IRB may set an ancillary review for further assessment of compliance with institutional 
data security policy.
21.4.1 How is the data being collected? (e.g., data capture using online surveys/questionnaire, 
surveys via email, observation of chat rooms or blogs, survey platform, application, or 
device)
Research staff will use PSU-owned electronic tablets for electronic data capture using REDCap (a secure 
electronic database provided by Penn State). Research staff and/or research participants will enter 
screening information (first name, last name, email address, phone number, mailing address, date of 
birth). Participants completing surveys at home will use their own device. Participants who complete 
surveys at the CRC will use a PSU-owned electronic tablet.
Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool is being used to collect dietary data. 
Abbott Freestyle Libre Pro System is being used for continuous glucose monitoring for 7 days at the 
beginning and end of the study. 
21.4.1.1
If you’ve indicated that data is being collected via a device or application (e.g. 
FitBit, Apple Watch, eye tracker, etc.), will the developer/external entity have 
access to the research data? 
 No 
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 Yes 
Abbott will have access to the de-identified data collected via Abbott Freestyle 
Libre Pro System. The sensor collects blood glucose data and it is downloaded using a 
Reader by study staff. The data will be transmitted from the Reader to the LibreView 
cloud platform. This system is encrypted to prevent unauthorized access.
The developer of the Self-Administered 24-Hour (ASA24®) Dietary Assessment 
Tool will have access to the collected de-identified data (see attachment ASA24 Data 
Security & Confidentiality Information).
21.4.2 Specify the level of data that will be stored electronically (refer to definitions at the top of this 
section – links to levels/storage: https://security.psu.edu/awareness/storage/  
  Level 1 (e.g. public data, de-identified)
  Level 2 (e.g. identifiable)
  Level 3 (e.g. PHI, SSN)
  Level 4 (e.g. Classified data)
21.4.3 Indicate where the electronic data associated with this research study will be stored (Check all 
that apply)
21.4.3.1
PSU - Penn State University and Commonwealth Campuses
•
Penn State IT provided database application:
  Penn State REDCap 
  Penn State Qualtrics
  Penn State, College, or Department IT managed file server, OneDrive, or SharePoint 
  Penn State GoogleDrive
•
Other – Specify the database application or server:
  Provide details about the data security features or attach security documentation 
provided by sponsor or group. 
Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool: Respondent data are 
protected using industry standard security controls. All data entered into the ASA24 
system at the respondent’s computer are encrypted by the internet browser (e.g., 
Chrome, Firefox, etc) while transmitted to ASA24 servers using Secure Socket Layer (SSL) 
Technology. SSL allows for the authentication of the sending and receiving computers. 
Only a particular study’s investigator(s) and the ASA24 operations team can access 
response data. Access is gained through usernames and strong passwords (see 
attachment ASA24 Data Security & Confidentiality Information).
CGM: The sensor collects blood glucose data and it is downloaded using a Reader. The 
data will be transmitted from the Reader to the LibreView cloud platform. This system is 
encrypted to prevent unauthorized access.
Please visit datastoragefinder.psu.edu for assistance with identifying appropriate data 
storage options. If the software to be used does not appear on that site, a software 
request form must be completed. 
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21.4.3.2
PSH/COM - Penn State Health/College of Medicine
•
Penn State IT provided database application:
  Penn State REDCap
  Penn State Qualtrics
  Penn State Health, College of Medicine, or Department IT managed file server
  Office365, OneDrive, or SharePoint
-
Specify the O365 tenant to be used (PSU, PSH)
  Oncore (Penn State Cancer Institute only)
  Florence eBinders
  External Institution’s REDCap
  Web-based system provided by the sponsor or cooperative group via contract
•
Other – Specify the database application or server:
  Provide details about the data security features or attach security documentation 
provided by sponsor or group. 
21.5
Will any type of recordings (e.g., audio or video) or photographs of the subjects be made during this 
study or will you interact with subjects via live video streaming(video chat)?
 No – skip to 21.6
 Yes – Live video chat ONLY without recording. If this is the ONLY box checked, complete 21.5.1 only. 
 Yes – Recording (audio, video, photographs, recording of video chat). If this is the ONLY box checked, 
skip to 21.5.2:
21.5.1 Select the video chat platform:
 PSH HIPAA Compliant Teams
 PSU Zoom
 Other: Specify: 
[Type text here if box is checked]
21.5.2 Select the type of recording or image being made and what is being used to record or capture 
the image:
 Audio – Describe what will be used to capture the audio:
[Type text here if box is checked]
 Video – Describe what will be used to capture the video:
[Type text here if box is checked]
 Photographs of the subjects – Describe what will be used to photograph the subjects and 
whether facial images will be captured or collected:
[Participants will be asked to take photos with their smart phones of saliva sample vials 
immediately after sample collection. The purpose of these photos is to capture a digital 
timestamp for the sample collection time for compliance with with recommended 
guidelines for salivary cortisol26. These photos may include the participant’s hand, but will 
not include facial images. Participants have been instructed not to include their faces in the 
image. Images will be uploaded to REDCap by study staff during sample return.]
 Recording of video chat
 PSH HIPAA Compliant Teams
 PSU Zoom
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 Other: Specify: 
[Type text here if box is checked]
 Other - Specify: 
[Type text here if box is checked]
21.5.3 Will any of the recordings be transcribed?
Note: If a transcription service outside of Penn State will be used, a business associate 
agreement or data transfer agreement may be needed. 
 No
 Yes – indicate who will be doing the transcribing? (Ex: Zoom, Rev.com, Datagain, 3Play 
Media). If necessary, please clarify if the transcription service is HIPAA compliant or not.
[Type protocol text here]
21.5.4 Will the recordings be destroyed or cleaned (removed of all identifiers)? If so, describe below.
[Type protocol text here]
21.6
Certificate of Confidentiality (COC) - Is the research biomedical, behavioral, clinical or other research 
that is funded by the National Institutes of Health (NIH)?
 Yes – this means at least one of the following is true: 
-
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 true, 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.
21.7
Does this research involve the generation of large-scale human genomic data as defined in NIH 
Genomic Data Sharing Policy (https://sharing.nih.gov/genomic-data-sharing-policy))?
  No
  Yes – describe the plan for de-identifying the dataset before sharing it with NIH-designated data 
repositories. 
[Type protocol text here]
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Note: Data sharing with an NIH-designated data repository may require execution of an institutional certificate. 
Please review the ‘Institutional Certification for NIH Genomic Data Sharing’ section of the Investigator’s Manual 
for information about seeking institutional certification.
21.8
Does this research involve data sharing to public/restricted data repositories or as part of a journal 
requirement?    
Data sharing is an important part of rigorous scientific discovery and the validation of results.  Planning 
for data sharing is strongly recommended.  Please refer to: 
https://libraries.psu.edu/about/departments/research-informatics-and-publishing/services/data-
management-and-sharing 
Data sharing includes sharing of identifiable, coded, or de-identified data.  The data can be shared with 
public or restricted data repositories.  Increasingly, journals require the sharing of data as a stipulation 
for publication.  NIH-funded studies require data sharing, unless explicitly granted an exception from 
the NIH.  
  No – skip to section 21.9
  Yes (strongly recommended as may be required for publication and future grant submission)
21.8.1
What type of data will be shared:  De-identified, coded, identifiable (if identifiable, list the 
identifiers that will be shared) 
  De-identified
  Coded (there is a study code ID being sent, but no identifiers with the study code)
  Identifiable – Specify the identifiers that will be shared:
De-identified data will be uploaded to a public data repository. 
 
21.8.2
What type of repository will be used to share the data: Public, controlled, etc.  Note: The 
specific name of the repository is not necessary. 
Public
21.9
Does this research involve transfer or disclosure of data and/or specimens to and/or from Penn State?
  No - skip to section 22.0
  Yes - answer the following questions:
21.9.1   Specimen and/or data are being transferred or disclosed (electronically or physically) TO 
Penn State. Please insert study information in first blank row. Please add additional rows as 
necessary for each individual entity, do not have more than one entry in a row. (Example provided in 
grey)
Sharing 
Entity (if 
international
, specify 
country)
Data or 
Specimen 
Type
Method of Transfer
Storage 
Location
Identifier
s (Refer 
to table 1 
in 21.1)
Linking 
List 
Location
Additiona
l notes, if 
needed.
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Quest 
Diagnostics 
Screening 
blood 
results
Online platform Quanum 
Lab Services Manager
REDCap, 
CRC, 
Chandlee 
Lab
Name, 
screening 
study 
code, date 
of birth
n/a 
Identifiers 
are 
included on 
screening 
bloods so 
that 
participants 
can provide 
these blood 
results to 
their 
medical 
clinic 
and/or 
primary 
care 
physician. 
The tests 
we do at 
screening 
are typical 
blood tests 
done for 
general 
health 
evaluation 
and 
therefore 
prospective 
participants 
often use 
these 
results for 
their annual 
physicals. 
This is 
viewed by 
participants 
as a benefit 
as it saves 
them the 
cost 
associated 
with paying 
for routine 
general 
health 
blood tests.  
If a study 
code was 
used for the 
blood 
results, it is 
likely that 
some 
medical 
clinics 
and/or 
physicians 
would not 
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accept the 
results. 
Self-
Administere
d 
24-Hour 
(ASA24®) 
Dietary 
Assessment 
Tool, NCI
Dietary 
data
Online 
platform: 
https://asa24.nci.nih.gov/
Onedriv
e
Study 
code
REDCap 
Onedriv
e
Abbott
Continuou
s 
glucose 
data
Online platform: LibreView: 
https://www.libreview.com
/
REDCap 
Onedriv
e
Study 
code
REDCap 
Onedriv
e
21.9.2  Specimen and/or data are being transferred or disclosed (electronically or physically) FROM 
Penn State. Please insert study information in first blank row. Please add additional rows as 
necessary for each individual entity, do not have more than one entry in a row. (Example provided in 
grey) 
Sharing 
Entity (if 
international, 
specify 
country)
Data or 
Specimen Type
Method of 
Transfer
Storage 
Location
Identifiers 
(Refer to 
table 1 in 
21.1)
Linking List 
Location
Additional 
notes, if 
needed.
EXAMPLE: US 
based or 
International 
based 
Institution 
name (if 
international, 
specify 
country)
Consent forms, 
questionnaires, 
activity data 
from FitBit, 
liver biopsy 
sample, biopsy 
results, audio 
recordings.
Aspera, Office 
365, REDCP, 
Sponsored 
platform/location
REDCap, 
Lab, CRC
Study 
code, 
Date of 
birth
  ONLY 
with 
External 
Entity
  External 
Entity and 
Penn State
  Penn 
State ONLY
Quest 
Diagnostics 
Blood
Quest 
carrier 
picks 
up 
the 
blood from the 
CRC
n/a
Name, 
screening 
study code, 
date 
of 
birth
n/a 
Identifiers 
are included 
on 
screening 
bloods 
so 
that 
participants 
can provide 
these blood 
results 
to 
their 
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medical 
clinic and/or 
primary care 
physician. 
The tests we 
do 
at 
screening 
are 
typical 
blood tests 
done 
for 
general 
health 
evaluation 
and 
therefore 
prospective 
participants 
often 
use 
these 
results 
for 
their annual 
physicals. 
This 
is 
viewed 
by 
participants 
as a benefit 
as it saves 
them 
the 
cost 
associated 
with paying 
for routine 
general 
health blood 
tests.  If a 
study code 
was used for 
the 
blood 
results, it is 
likely 
that 
some 
medical 
clinics 
and/or 
physicians 
would 
not 
accept 
the 
results. 
UP/Commonwealth Data Transfer: 
Office of Sponsored Programs - Data transfers or disclosures may require a Data Use Agreement (DUA). If the 
third party is requiring us to sign a contract regarding the data, this contract must go through the Office of 
Sponsored Programs https://www.research.psu.edu/osp/overview-pages/data-use-agreements. 
PSU/Commonwealth Material Transfer: 
Office of Technology Transfer - All material transfers, either sending or receiving, require a Material Transfer 
Agreement (MTA). Please contact the Office of Technology Transfer for more information. https://ott.psu.edu/ 
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Penn State Health/College of Medicine Data transfer: 
Office of Research Affairs - Data transfers or disclosures may require a Data Use Agreement (DUA). If the Office 
of Research Affairs has not yet been contacted, please email e-contracts@pennstatehealth.psu.edu. If a third 
party is requiring us to sign a contract regarding the data, the contract must go through the Office of Research 
Affairs. Please submit at the following link: https://pennstatehershey.tfaforms.net/267.
Penn State Health/College of Medicine Material transfer:
Center for Medical Innovation - All material transfers, either sending or receiving, require a Material Transfer 
Agreement (MTA). If a MTA Intake Form has not been completed for this material transfer, please go to 
https://pennstatehershey.tfaforms.net/744 and complete the on-line MTA intake form. If you have any 
questions, please email CMI@pennstatehealth.psu.edu.
22.0
Identifiable Data and Specimen Banking for Future Undetermined Research
If this study is banking 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 the above sections regarding whether or not data and/or specimens will be associated 
with identifiers (directly or indirectly). If there are no plans to use identifiable data/specimens for future, 
undetermined research, then this section is NOT applicable.
[Do not type here]
22.1
Data and/or specimens being stored
Identify what data and/or specimens will be stored, and the data associated with each specimen.
Not applicable
22.2
Location of storage
Identify the location where the data and/or specimens will be stored.
Not applicable
22.3
Duration of storage
Identify how long the data and/or specimens will be stored. If data and/or specimens will be stored 
indefinitely, indicate such. 
Not applicable
22.4
Access to data and/or specimens
Identify who will have access to the data and/or specimens.
Not applicable
22.5
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.
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Not applicable
22.6
Process for returning results
Describe the process for returning results to participants from the banked data and/or specimens.
Not applicable
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