The Anti-Inflammatory Effects of Exercise and Peanut Consumption
Phase: NA
Conditions: Peanut Consumption, High Intensity Aerobic Exercise
Sponsor: New York State Psychiatric Institute

NEW YORK STATE PSYCHIATRIC INSTITUTE 
INSTITUTIONAL REVIEW BOARD 
MEMORANDUM 
 
Signed copy on file at IRB. 
EN/AW/collins 
May 25, 2018 
TO:   
RICHARD P. SLOAN, PHD 
 
FROM:  
Dr. Edward Nunes, Co-Chair, IRB 
 
 
Dr. Agnes Whitaker, Co-Chair, IRB 
 
SUBJECT:  
EXPEDITED APPROVAL OF PROTOCOL AMENDMENT 
 
 
The amendment to your protocol #7466 entitled: THE ANTI-INFLAMMATORY EFFECTS 
OF EXERCISE AND PEANUT CONSUMPTION (To use the Columbia RecruitMe 
platform for subject recruitment, as per the 5/10/2018 memorandum) has been 
approved by the Psychiatric Institute - Columbia University Department of Psychiatry 
Institutional Review Board. 
 
Please note that this does not change the IRB's cycle of review.  A progress report 
and an application for continuing review will be required 2 months before the 
study's approval is due to expire: (4/30/2019). 
 
 
 
 
 

Protocol Summary Form
7466
Sloan, Richard
Page 1 of 7
Protocol Title:
The Anti-Inflammatory Effects of Exercise 
and Peanut Consumption
Protocol Number:
7466
First Approval:
05/15/2017
Expiration Date:
04/30/2019
Version Date:
05/25/2018
Contact Principal Investigator:
Richard Sloan, PHD
Email: rps7@columbia.edu
Telephone: 646-774-8940
Co-Investigator(s):
Martin Picard, PHD
Research Chief:
Richard Sloan, PHD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am proposing an amendment only to an existing protocol
Division & Personnel
Division
What Division/Department does the PI belong to?
Behavioral Medicine/Psychiatry
Within the division/department, what Center or group are you affiliated with, if any? 
none
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.

Protocol Summary Form
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Sloan, Richard
Page 2 of 7
Wahida Karmally, Dr. PH RDN, CDE, CLS Director of the Bionutrition Research Core of the Columbia 
University Medical Center Irving Institute for Clinical and Translational Research and Associate Research 
Scientist and Lecturer in Dentistry at Columbia University
Amendment
Describe the change(s) being made 
We would like to use the Columbia RecruitMe platform for subject recruitment.
Provide the rationale for the change(s) 
We hope that this will increase our recruitment rates.
Comment on the extent to which the proposed change(s) alter or affect risks/benefits to subjects 
N/A
Comment on if the proposed change(s) require a modification to the Consent Form (CF)
No.
Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Collection of Biological Specimens
   Medication-Free Period or Treatment Washout
Population
Indicate which of the following populations will be included in this research
   Medically and Psychiatrically Healthy Subjects
   Adults
   Employees or Students
Research Support/Funding
Will an existing internal account be used to support the project?
Yes
Describe internal account
This pilot study will be supported by Division of Behavioral Medicine funding.
 
Under: Funding Source #1 

Protocol Summary Form
7466
Sloan, Richard
Page 3 of 7
Is the project externally funded or is external funding planned?
No
Study Location
Indicate if the research is/will be conducted at any of the following
   Other Columbia University Medical Center Facilities
This protocol describes research conducted by the PI at other facilities/locations
No
Uploaded Protocol Summary Form
Upload Document
Select file to upload.
Peanuts_PSF_051018_Bolded.pdf
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
We will enroll and randomly assign 30 sedentary, healthy overweight men and women to two groups. 
Participants will either start by consuming peanuts for 4 weeks, and then go on to exercise at high intensity 
intervals (HIIT) for 4 weeks, or the reverse order. We will test and compare the effect of peanuts and 
exercise on inflammation and heart rate variability as indicators of heart health. Specifically, we will 
measure inflammation in the blood because there is evidence that higher inflammation is found in heart 
disease patients [1, 2]. There is also evidence that inflammation is related to death as a result of heart 
disease in healthy individuals [3-5]. Finally, there are ongoing trials targeting these markers to improve 
heart health (Entrace, CIRT, CANTOS[bs3] ). We hypothesize that peanuts and exercise will reduce 
inflammation. We also expect to find less inflammation because exercise and peanut consumption activate a 
part of the nervous system that has been shown to cause a similar effect.
Additionally, previous studies show that inflammation involves the mitochondria in the cell, the part of the 
cell that produces energy [57]. For this reason, we expect that exercise and peanuts will cause changes in the 
mitochondria. We will test and compare mitochondrial activity in response to peanut consumption and 
exercise.

Protocol Summary Form
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Sloan, Richard
Page 4 of 7
Description of Subject Population
Sample #1
Specify subject population
Overweight or obese (BMI 27-34.9 kg/m2), but otherwise healthy adults (21-45 years of age) 
Number of completers required to accomplish study aims
20
Projected number of subjects who will be enrolled to obtain required number of completers
30
Age range of subject population
21-45
Gender, Racial and Ethnic Breakdown
We will aim to recruit 15 male and 15 female participants in proportions comparable to those in the CUMC 
community (17% African American, 11% Hispanic, 16% Asian, and 48 % white).
Description of subject population
Overweight or obese (BMI 27-34.9 kg/m2), but otherwise healthy adults  (21-45 years of age) 
Recruitment Procedures
Describe settings where recruitment will occur
Recruitment will occur through flyers posted in CUMC and NYSPI facilities, the surrounding community, 
and the Columbia RecruitMe portal.
How and by whom will subjects be approached and/or recruited? 
Recruitment will occur through flyers posted in CUMC and NYSPI facilities, the surrounding community, 
and the Columbia RecruitMe portal.
How will the study be advertised/publicized? 
Recruitment will occur through flyers posted in CUMC and NYSPI facilities, the surrounding community, 
and the Columbia RecruitMe portal.
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT03212144
Concurrent Research Studies

Protocol Summary Form
7466
Sloan, Richard
Page 5 of 7
Will subjects in this study participate in or be recruited from other studies? 
No
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
Yes
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
No
Describe procedures used to obtain consent during the screening process 
After phone screening to determine eligibility, participants will complete the Baecke Physical Activity 
Questionnaire. Those who are regular exercisers, defined as a score of > 2 on this 5-point scale, will be 
excluded from further participation.
Describe Study Consent Procedures
Informed consent will be documented with a signed consent statement giving a description of the study in 
detail. In the Consent Form and through discussion with a research assistant, participants will be advised 
fully of the study procedures, time required, the possible risks and benefits of participation, their right to 
refuse participation in the study without prejudice, their right to terminate participation at any moment 
without prejudice, and the name and telephone number of the Investigators.
Indicate which of the following are employed as a part of screening or main study consent procedures
   Consent Form
Justification for Waiver or Alteration of Consent
Waiver of consent is requested for the following
During a phone screen, we will request basic information to determine initial eligibility for the study.
Explain why your research can not be practicably carried out without the waiver or alteration
Determination of eligibility is based on a series of steps, beginning with a brief telephone screen after 
receiving verbal permission from participants to answer questions about the most basic eligibility matters; 

Protocol Summary Form
7466
Sloan, Richard
Page 6 of 7
age, height, weight. Those meeting these qualifications will be invited to continue with the study or can be 
excluded.  Those who are eligible to continue will come to the Medical Center for an in-person session and 
provide informed consent before providing any additional information. 
Describe whether and how subjects will be provided with additional pertinent information after participation
Information will not be provided to subjects after participation.
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
acosta, carlos
Alphonsus, Andrea
Lauriola, Vincenzo
Mahmoodi, Amir
Type in the name(s) not found in the above list
Methods to Protect Confidentiality
Will the study be conducted under a certificate of confidentiality?
No
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
Yes
Please describe and indicate total amount and schedule of payment(s). 
Include justification for compensation amounts and indicate if there are bonus payments.
Participants will receive $25 for each blood draw, $25 for each sub-maximal cardiopulmonary exercise test, 
and $50 if they achieve 85% adherence to both the exercise and dietary arms of the study, totaling at most 
$250. Payments for the blood draws and exercise tests will be made after each test.
Uploads
Upload copy(ies) of unbolded Consent Form(s)
Peanuts_CF_051018_UnBolded.pdf
Upload copy(ies) of bolded Consent Form(s)
Upload copy(ies) of recruitment materials/ads to be reviewed
Peanuts_Flyer_Unstamped.pdf

Protocol Summary Form
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Sloan, Richard
Page 7 of 7
Upload copy(ies) of the HIPAA form
Peanuts_HIPPA-Form-A.pdf
Peanuts_HIPPA-NYSPI.pdf
Peanuts_Phone-Screen-Waiver.pdf
Upload any additional documents that may be related to this study

Uploaded Protocol Summary Form 
1 
 
 
 
 
 
Cover Page  
 
 
Protocol Number: 
7466 
Version Date: 5/10/2018 
Protocol Title: The Anti-Inflammatory Effects of Exercise and Peanut Consumption 
Principal Investigator: Richard P. Sloan, PhD 
Email:rps7@columbia.edu 
Telephone:  646-774-8940 
Office: 
Cell Phone: 
 
 
 
Lay Summary  
 
This section is intended to provide a basic overview of the study including a description of its purpose, methods, and  
subject population.  The summary should provide a concise overview of the study for non-scientific and scientific 
members of the IRB. Please avoid medical or technical terminology. In general, the abstract of a grant does not provide 
a suitable lay summary. 
Please also paste of a copy of the Lay Summary into the PRISM PSF Form. 
We will enroll and randomly assign 30 sedentary, healthy overweight men and women to two groups. Participants will 
either start by consuming peanuts for 4 weeks, and then go on to exercise at high intensity intervals (HIIT) for 4 weeks, 
or the reverse order. We will test and compare the effect of peanuts and exercise on inflammation and heart rate 
variability as indicators of heart health. Specifically, we will measure inflammation in the blood because there is 
evidence that higher inflammation is found in heart disease patients [1, 2]. There is also evidence that inflammation is 
related to death as a result of heart disease in healthy individuals [3-5]. Finally, there are ongoing trials targeting these 
markers to improve heart health (Entrace, CIRT, CANTOS[bs3] ). We hypothesize that peanuts and exercise will reduce 
inflammation. We also expect to find less inflammation because exercise and peanut consumption activate a part of the 
nervous system that has been shown to cause a similar effect. 
Additionally, previous studies show that inflammation involves the mitochondria in the cell, the part of the cell that 
produces energy [57].  For this reason, we expect that exercise and peanuts will cause changes in the mitochondria. We 
will test and compare mitochondrial activity in response to peanut consumption and exercise. 
 
Background, Significance, and Rationale  
 
In this section, provide a brief summary of the status quo of the relevant work field, and how the proposed study will 
advance knowledge. Specifically, identify the gaps in knowledge that your project is intended to fill. If no gaps exist that  
are obviously and directly related to your project, explain how your proposed research will contribute to the overall 
understanding of your field. Describe potential impacts of your project within your field of study and in a broader context. 
Provide a critical evaluation of existing knowledge. The literature review does not have to be exhaustive. 
Consensus panels consistently recommend that elements of a healthy lifestyle include consumption of fruits, vegetables, 
whole grains, nuts, and fish and increased physical activity for prevention of heart disease [6]. Just as consistently, 
Americans ignore this advice. In 2012, <1% of all US adults met 4 of 5 healthy dietary goals and nearly one third engaged 

Uploaded Protocol Summary Form 
2 
 
 
 
 
in no aerobic leisure-time physical activity [7].  Simply put, people find it extremely difficult to achieve these health- 
promoting dietary and activity goals [8]. 
Certain lifestyle modifications, e.g., nut consumption and aerobic exercise, appear to exert cardioprotective effects. A 
substantial body of evidence now demonstrates the beneficial impact of nut consumption on cardiovascular disease 
outcomes and all-cause mortality. In the Adventist Health Study, participants who consumed nuts 5 or more times per 
week had significantly reduced risks of both fatal coronary heart disease and nonfatal myocardial infarction [9]. The  
Iowa Women's Health Study and the PREDIMED trial reported similar findings [10-12]. Nut consumption was associated 
with a decreased prevalence of risk factors for CVD in 13,292 participants in NHANES [13]. Very recent studies report 
that nut consumption was inversely associated with total mortality and with deaths due to heart disease, cancer, and 
respiratory disease in over 115,000 women and men in the Nurses’ Health Study and the Health Professionals Follow-up 
Study [14] and in ethnically diverse cohorts of over 200,000 participants [15]. 
Observational and intervention studies of nut consumption also have shown reductions in various chronic diseases 
mediators, including oxidative stress [16, 17], hyperglycemia [13, 18], hyperlipidemia [10, 18], blood pressure [19, 20], 
cardiovascular autonomic regulation [20], and endothelial dysfunction [11]. Nut consumption may have anti- 
inflammatory effects [21, 22], a cardioprotective mechanism of particular interest. 
Similarly, many studies report that aerobic conditioning enhances vagally mediated high frequency (HF) HRV [23-27] and 
has anti-inflammatory effects [28-30].  Finally, studies from our group [31, 32] and others [33-37] show modest but 
consistent inverse relationships between HRV and inflammatory indices, often in large and nationally representative 
datasets.  Thus, evidence suggests the possibility that nut consumption and exercise could result in increases in HRV and 
reduction of inflammation, outcomes that are associated with cardioprotective effects. 
However, this evidence is weaker than generally assumed.  There appear to be no studies of the anti-inflammatory 
effects of peanut consumption. Many studies of the effect of exercise on heart rate [38-40] or HRV [23, 41-43] report no 
effect or no difference between trained and sedentary participants and many that do show effects are cross-sectional 
comparisons of highly trained athletes with sedentary controls or longitudinal studies of training that have only a small 
number of participants [23, 44], lack a control group [45], or include only men [24, 26, 27, 46-49]. Thus, the data on the 
effect of exercise on inflammation must be regarded as promising but not fully established. 
 
 
With regards to mitochondria, previous studies reveal that systemic inflammation involves mitochondrial signaling 
through several routes [57, 58]. A direct pathway by which this occurs is the leaking of mitochondrial circular DNA 
(mtDNA) in the systemic circulation in response to mitochondrial dysfunction, cellular damage or oxidative stress [57]. 
MtDNA are recognized as foreign or immunogenic and thereby trigger inflammation [59]. The indirect course involves 
the release of immunogenic molecules in the cell cytoplasm that induce proinflammatory gene response and the release 
of cytokines in various cells [59]. Finally, mtDNA encodes and modulates the electron transport chain whereby it ensures 
the proper detoxification of reactive oxygen species (ROS), and hence mitochondria can carry out its functions to  
produce energy and regulate major stress-response axes [60]. It follows that mitochondrial dysfunction may be directly 
associated with various pathologic states [60]. 
 
 
The potential pathophysiology of mitochondrial dysfunction requires a better understanding of the efficacy of various 
interventions in regulating mitochondrial function. Recent findings contend that vagus nerve activation and the release 

Uploaded Protocol Summary Form 
3 
 
 
 
 
of acetylcholine prevents inflammatory stimulation and mtDNA release [58]. Therefore, given the abovementioned 
studies linking nut consumption to reduced oxidative stress [16,17], and exercise to high vagal activity [27], we endeavor 
to examine the response of mitochondria to both interventions. Particularly, we will extract peripheral blood 
mononuclear cells (PBMCs) to examine mtDNA and mitochondrial enzymatic activity. 
Finally, with regards to the duration of exposure to both interventions, several studies of the effect of nut consumption 
on a variety of outcomes including inflammatory and autonomic show effects after 4 weeks. We modeled our 
intervention on those studies. Similarly, recent studies of high intensity interval training show effects on a variety of 
outcomes with as little as 2 weeks of training. Most use a 4-week program. 
Selecting peanuts over other nuts was a compromise taking into consideration several factors. The best evidence for 
anti-inflammatory effects of nuts is in interventional studies of pistachio nuts. For example, West et al. [19] and Sauder 
et al. [20] found lipid lowering, anti-hypertensive, and anti-inflammatory effects of 4 weeks of consumption of pistachio 
nuts. The best evidence on peanut consumption comes from an observational study by Bao et al. [14] who showed 
substantial effects on mortality from diets heavy in a variety of nuts including peanuts. Thus, although the evidence of  
an anti-inflammatory effect of nuts is stronger for pistachios, peanuts are much cheaper and since the overall premise of 
this study is to test a public health intervention, we decide to test peanuts in this pilot grant. 
This application is based on the discrepancy between consensus recommendations and the reality of health behavior 
change, and is informed by the opportunity to exploit what appears to be a common pathway by which nut 
consumption and exercise may exert their cardioprotective effects: the cholinergic anti-inflammatory reflex {Tracey, 
2002 #6544}. Through this reflex, acetylcholine released by the vagus nerve effectively inhibits cytokine production in 
the principal organs of the innate immune system, the reticuloendothelial system in the spleen and the liver [50, 51]. 
 
Specific Aims and Hypotheses  
 
Concisely state the objectives of the study and the hypothesis or primary research question(s) being examined.  There 
should be one hypothesis for every major study procedure or intervention.  For pilot studies, it is important not to   
overstate the study's objectives.  If there are no study hypotheses, describe broad study goals/aims. 
Hypothesis/Objectives 
 
We propose to conduct an innovative pilot crossover non-inferiority trial to collect preliminary data with the aim, 
ultimately, of testing the hypothesis that the anti-inflammatory effect of peanut consumption is at least as great as that 
of short term (four week) high-intensity aerobic exercise. 
 
Our aims are to test the hypotheses that: 
 
1. Plasma levels of IL-6 and TNF-α are reduced by peanut consumption and that this effect is at least as great as the 
effect of high-intensity aerobic exercise. 
2. Consistent with the cholinergic anti-inflammatory hypothesis, peanut consumption and high intensity 
exercise will be associated with an increase in heart rate variability. 
 
3. Mitochondrial enzymatic activity is altered in response to both interventions: exercise and peanut consumption 

Uploaded Protocol Summary Form 
4 
 
 
 
 
This section details your study sample(s) and addresses the requirement for risk minimization. 
You may choose to divide your sample by population (healthy controls vs. subjects) or by procedure (subjects who will 
have an MRI) and then define different sets of criteria for each. 
For each sample, create or insert a table to describe detailed criteria for study inclusion and exclusion and the method 
you will use to ascertain each criterion. The method of ascertainment may describe tests, scales and instruments.  When 
relevant, indicate the level of training of the person who will make the assessment (e.g. clinical interview by a 
psychiatrist). 
Inclusion/Exclusion Criteria needs to be numbered and listed in outline form (see Table template below). 
 
INCLUSION CRITERIA 
METHOD OF ASCERTAINMENT 
Of either sex, age 21–45 years 
Telephone screen 
English-speaker 
Overweight or obese 
BMI 27.0 – 34.9 kg/m2 
Sedentary 
Baecke Physical Activity Questionnaire of 
<10 
Home computer access 
 
Participant disclosure 
 
 
EXCLUSION CRITERIA 
METHOD OF ASCERTAINMENT 
1. Cardiovascular disease 
Medical History Interview 
2. Uncontrolled high blood pressure (blood pressure ≥ 140/90). 
Individuals with controlled hypertension (i.e. under medical 
treatment) and blood pressure lower than 140/90 will not be excluded. 
Measurement taken at 
consent before eligibility is 
determined 
3. Current or recent (evidence of disease x 5 years) non-skin neoplastic 
disease or melanoma. Prostatic carcinoma will not be grounds for 
exclusion. 
Medical History Interview 
4. Active hepatic disease (not a history of hepatitis) or primary renal 
disease requiring dialysis, primary untreated endocrine diseases, e.g., 
Cushing’s disease or primary hypothalamic failure or insulin dependent 
diabetes (Type I or II). 
5. HIV infection 
6. Pregnant or lactating (participation allowed 3 months after ceasing 
lactation). 
7. Medications that alter inflammation or autonomic nervous system 
activity. 
8. Any history of psychosis or ECT 
Inclusion/Exclusion Criteria 

Uploaded Protocol Summary Form 
5 
 
 
 
9. Psychotic disorder (lifetime) 
10. Current or recent (past 5 years) Major Depressive Disorder, Bipolar 
Disorder, or Anxiety disorder 
11. Current or recent (within past 12 months) alcohol or substance 
abuse or dependence. Recent use (past month) of recreational drugs. 
Medical History Interview 
12. Probiotic and dietary supplements that affect inflammation or the ANS 
13. Physically active 
CPET1 
VO2max 
(ml/kg/mi 
n) 
VO2max 
(ml/kg/min) 
Age (yrs) 
Male 
Female 
21-29 
>41.0 
>35.2 
30-39 
>39.5 
>33.8 
40-49 
>37.6 
>32.3 
14. Peanut allergy in subject or in family of subject. Subjects who are 
unsure of their allergy status will be excluded. 
Diet Interview 
15. Hormonal Birth Control 
Telephone Screen 
 
 
 
 
Study Procedures  
 
Provide a clear, concise narrative of study procedures with special attention to the subjects' involvement.  Detail the  
overall study timeline and location of study procedures, list all interventions, assessments and interviews, estimate the 
duration of each procedure, provide dosing schedules, identify study personnel involved in each procedure, and provide 
credentials for relevant personnel.  For complicated study designs, we strongly encourage attaching tables, flow-charts, 
and study algorithms. 
Sedentary, overweight or obese but otherwise healthy 21-45 year old participants from Columbia University Medical 
Center/New York Presbyterian Hospital, and surrounding community, will be recruited through posted flyers and the 
Columbia RecruitMe online platform. After screening and eligibility determination through physical activity 
assessment and medical history interview they will provide informed consent. Participants must agree to maintain 
constant body weight(<±3%) and current levels of physical activity, except for the study interventions, throughout the 
protocol. They must also agree to abstain from omega-3 fatty acids supplements, high fat fish consumption 
(>8oz/week), and nuts (besides the peanuts given). Additionally, high quantities (>1 serving/day) of flax seeds, chia 
seeds, soy, canola, including oils, or food products that contain these ingredients in high quantities must be avoided, 
but subjects can otherwise maintain their current diet. The experimental protocol is presented in the Flowchart. 

Uploaded Protocol Summary Form 
6 
 
 
 
 
 
 
 
 
Qualifying participants will undergo a two-week run-in period, first of control snack consumption and then stretching to 
screen for adherence. They will then undergo a submaximal cardiopulmonary exercise test, sCPET 1, to establish 
baseline VO2max and confirm eligibility as a sedentary individual. They will then proceed to Lab Session 1 . 
Women will be asked to wait until they are in the post-ovulatory mid-luteal phase of their menstrual cycle (as indicated 
by a home ovulation kit) to schedule the first sCPET, such that all their later sCPET and laboratory tests will similarly align 
with the mid-luteal phase. 
 
Women participants receive a 7-day ovulation home kit at the start of the study to estimate the ovulation date. The kit 
contains strips on which participants are asked to urinate every day following the end of their menstrual period until 
ovulation is detected – measured by a surge in luteinizing hormone (LH), also known as the onset of the luteal phase. All 
study tests are scheduled for this period within the menstrual cycle. 

Uploaded Protocol Summary Form 
7 
 
 
 
 
Participants will then be randomized to either 4 weeks of high intensity interval aerobic exercise or peanut consumption 
(2 times a day). Participants starting with peanuts will meet with the research assistant/dietitian who will assess their 
eating patterns by implementing a 24 hour recall. Dietary information will be used to help guide the subjects in 
maintaining an isocaloric diet during the protocol. Additionally, the Miflin St. Jeor calculation will be used to determine 
the daily number of calories needed for each subject in order to maintain their weight. 
 
 
All adherent and qualifying subjects go on to Laboratory Session 1 (anthropomorphic indices, HRV, fasting blood drawn). 
Participants starting with the exercise intervention will be instructed on how to use the exercise facility, and participants 
starting with peanuts will be given peanuts and instructed on food substitution in order to maintain an isocaloric diet. All 
contact with participants about group assignment, test scheduling, adherence monitoring, etc. is conducted by trained 
research assistant “coaches.” 
 
 
After the first 4-week intervention (exercise or peanuts) all participants will undergo Laboratory Session 2 and sCPET 2, 
and proceed to a 4-week washout period. 
 
 
By the end of the washout period, all participants will undergo sCPET 3. Participants who cross-over to the dietary 
peanut intervention will meet with the research assistant/dietitian to assess their eating patterns to inform instructions 
on maintaining an isocaloric diet during the protocol. Participants who cross-over to the exercise intervention will be 
instructed on how to use the exercise facility. All participants will return for Laboratory Session, and participants who 
will be consuming peanuts will be given peanuts and instructed on food substitution in order to maintain an isocaloric 
diet. 
 
Following the second 4-week intervention, all participants return for follow-up Laboratory Session 4 and sCPET 4. All 
outcome variables (VO2max, HRV, inflammation, and PBMC’s) and control variables (weight, body composition and diet 
quality and physical activity independent of training) will be collected at 4 time periods in the study.  All contact with 
participants about group assignment, test scheduling, adherence monitoring, etc. is conducted by trained research 
assistant “coaches.” 
 
 
Two-Week Run-in Period 
In previous projects, the run-in period has allowed us to identify participants likely to adhere to the protocol and thus 
has substantially reduced dropout. 
 
 
For the first week, participants will eat a run-in snack, commercially available pita chips, twice a day as between meal 
snacks. Research assistants will collect the numbered pita packets at the end of the week to check for compliance. Only 
participants who consume at least 11 out of the 14 pita snacks and maintain weight will continue to the second week of 
the run-in. 

Uploaded Protocol Summary Form 
8 
 
 
 
 
For the next week, participants will be instructed on how to perform the stretching phase of the run-in and how to use 
the Polar Heart Rate (HR) monitor. Participants will complete 4X/week for 30 min of stretching at home while wearing 
the Polar HR monitor. Coaches will provide detailed instructions on how to complete the stretching. 
Stretches consist of arm circles, neck rotations, toe reach, gluteal stretches, lateral leg swings, achilles stretch and ankle 
rolls. Adherence will be monitored using gym attendance records and HR monitor data. Only participants who perform 
at least 3 out of the 4 stretching sessions can continue on to the sCPET, Lab Session 1, and randomization. 
 
 
Submaximal Cardiopulmonary Exercise Test 
We will administer a sub-maximal test using a pre-recorded audiotape with instructions and timed metronome rhythms 
and a 12” step (see figure). The participant will listen to the test instructions and will commence stepping to the 
metronome beat at 15 steps per minute for a 2-minute period following which heart rate, measured by telemetry 
(Model RS400, Polar Electro OY, Finland) and rating of perceived exertion on the Borg Scale 
(see figure) will be recorded (Test Level 1). The step rate then 
will be increased to 20 steps per minute for an additional 2 
minutes, when heart rate and rating of perceived exertion will 
again be recorded (Test Level 2). The test will continue with 
additional 2 min increments increasing the step rate by 5 
steps/min until the participant reaches a heart rate of 80% of 
the predicted maximal heart rate equation (220-age) or 
estimates perceived exertion at a score of 17 or greater. The 
maximum test duration will be 10 minutes (i.e., Test Level 5). 
Each individual’s aerobic capacity then will be predicted by plotting the exercise heart 
rates on a prepared graphical datasheet, drawing a visual line of best fit between the 
data points, projecting the line up to maximum heart rate (HR) and estimating the 
corresponding aerobic capacity (ml O2/kg/min) from the x-axis.  This estimate of aerobic 
capacity will be used to establish target heart rate for the 4-week training period. 
Additionally, as illustrated in inclusion criteria chart, the sCPET1 will be used to determine sedentary status which is a 
requirement for subjects. 
 
 
Dietary Assessment 
Participants who have successfully completed the run-in, the sCPET1, who have been randomized, and who are 
beginning the peanut intervention will meet with a research assistant who will assess their eating patterns using a 24 
hour recall (USDA Multiple-Pass Method [52]). This will inform recommendations for a stable, isocaloric eating pattern. 
Subjects must refrain from consuming foods or supplements listed in exclusion criteria. Caloric needs are calculated 
using the Miflin-St Jeor prediction equation [53]. 
 
 
Participants must abstain from omega-3 fatty acids supplements and high fat fish consumption (8oz/week), nuts, flax 
seeds and chia seeds, soy (including soybean oil and canola oil) and food products that contain these ingredients in high 

Uploaded Protocol Summary Form 
9 
 
 
 
 
quantities (>1 serving/day) during the study but can otherwise maintain their current diet. Participants are assessed for 
alcohol, caffeine, and cocoa consumption and must maintain their levels of intake of throughout the study. 
 
 
Laboratory Testing Sessions 
Participants abstain from any physical exercise for a 24-hour period prior to each testing session to control for acute 
effects of exercise on inflammatory markers.  Participants arrive for Laboratory Sessions in the morning after an 
overnight fast. 45 ml (9 teaspoons) of venous blood will be drawn for cytokine, PBMCs and hormone analysis.  For 
women, laboratory sessions are scheduled in the mid-luteal phase of the menstrual cycle, to control for cycle effects on 
Heart Rate Variability [54]. After the blood draw, they receive a light breakfast providing 15% daily energy intake as 
established during the dietary assessment. Waist circumference is measured with a Gulick anthropometric tape. Height 
is measured using the Seca 214 Portable Height Rod (Seca Corp., Hamburg, Germany).  Weight and body composition 
are measured using a Tanita BF-350 monitor (Tanita UK Ltd., Middlesex, UK). 
Participants then are instrumented with ECG leads and respiration monitoring bands and rest quietly in the supine 
position for 5 min, after which 20 min of resting ECG and respiration data are collected. These data are collected in all 
Laboratory Sessions. 
 
 
Treatment Conditions 
In this crossover design, participants are randomly assigned to either the peanut condition followed by aerobic exercise 
or aerobic exercise followed by the peanut condition. Following the guidelines for non-inferiority trials, the exercise 
intervention, as the more widely accepted anti-inflammatory treatment, functions as the comparison for the peanut 
intervention. 
 
 
Peanut Diet 
Regular daily caloric intake of each subject will be estimated using data from 24hr recalls, the Miflin-St. Jeor equation, 
and stress/activity factors. Participants will consume dry roasted, unsalted peanuts equivalent to approximately 10% of 
daily energy intake twice a day (total=20% total daily energy intake), which will range from approximately 400kcal to 600 
kcal, which corresponds to about 2.4 ounces to 3.6 ounces. Peanuts will replace protein and fat containing foods so that 
the daily caloric intake will not differ from participants’ typical diet. Nutrient content will be analyzed by Covance 
Laboratory (Madison WI). To assess compliance, participants will be asked to bring back the empty, numbered peanut 
packets by the end of every week and will be given new packets weekly. Additionally, subjects will be informed that they 
will be randomly assessed weekly for compliance; they will be asked to provide details of when and where they 
consumed their packets the previous day. Research assistants will provide guidance on how to maintain compliance. 
 
 
High Intensity Interval Training (HIIT): 
Based on previous studies [55], participants will engage in 4 training sessions per week over a 4-week period, with 24 
hour rest-periods between each training day. Participants will have the option to exercise either at the PlusOne Fitness 
Center at CUMC/NYPH, or at home on a Sunny Folding Climbing Stepper (Sunny Health & Fitness, Los Angeles) which 
will be delivered to the participant via UPS or FedEx, and be retrieved by Behavioral Medicine staff at the end of the study, 

Uploaded Protocol Summary Form 
1
 
 
at no cost to them. Participants will indicate which exercise modality they choose at the informed consent appointment, 
and those who elect to do the home-based program will have the Sunny Stepper delivered to their home after the 2-week 
run-in period is completed.  Each session begins with a 3 min low intensity warm-up, and then participants exercise as 
rapidly as they can for 20 seconds, aiming to reach 85% of their maximum heart rate as established during the 
submaximal cardiopulmonary exercise testing (sCPET) (see Sec D.3.4.). This 20 second period is followed by 40 seconds 
of low intensity exercise. Participants complete 8 such intervals for sessions 1 and 2, 10 intervals for sessions 3 and 4, 
and 12 intervals thereafter. A brief training program similar to this yielded a 9% increase in VO2max in only 12 days. 
High Intensity Interval Training (HIIT) also has been shown to be safe.  In over 175,000 hours of cardiac rehabilitation, 
the cardiovascular event rate was extremely low [56]. 

Uploaded Protocol Summary Form 
10 
 
 
 
 
 
Criteria for Early Discontinuation  
 
Define criteria that will be used to exit or drop subjects from the study.  Indicate the time points when such criteria will be 
applied, and describe the rating instruments, parameters, and thresholds that will lead to a decision to terminate a 
subject's participation.  In addition, explain procedures for managing subjects who are dropped from the protocol. 
For treatment studies: To minimize risks to subjects, operationalized drop-out criteria should be defined so that subjects 
who worsen, or in some cases, fail to improve, are removed from the study and offered standard care. The threshold for 
drop-out should consider the level of risk associated with non-improvement for the specific disorder, the availability of 
alternatives, and the typical required duration of treatment. For example, emergence of suicidal intent, or psychosis, 
should prompt immediate clinical evaluation and withdrawal from the study. 
Subjects will be dropped from the study at any point during the entire study in the event of serious illness or injury, or if 
they develop an allergy to peanuts or at any point during the exercise phase if an injury occurs. All participants will have 
been carefully screened prior to the initiation of the exercise protocol to minimize the risk of adverse events. 
Participants will be required to present a note from a physician indicating medical clearance for exercise training. 
 
Blood and other Biological Samples  
 
Describe how the sample will be used and indicate, when relevant, the amount of the sample.  The IRB wants to know 
that the sample is sufficient for the purposes of the study, but that sampling is limited to what is minimally necessary. 
If you’ve indicated that you intend to store a sample for future use, indicate where the sample will be stored, how long 
the sample will be stored, and to what purposes the sample will eventually be put.  Check the IRB website at  
http://irb.nyspi.org/irbdnn/Policies/GeneticResearch/tabid/96/Default.aspx   for specific guidance and additional 
information about future use of DNA samples. 
 
Assay mL 
Purpose 
blood 
45 
ml 
Cytokine (plasma), neuroendocrine factors (plasma), and peripheral blood mononuclear cells 
isolation (PBMCs) 
 
 
Assessment Instruments  
 
List all assessment instruments, indicate who will administer them, and provide an estimate the duration of each.  The 
IRB wants to know that assessments instruments are appropriate measures for the purposes of the study and are no 
more burdensome than is necessary.  The IRB will consider the burden of assessment instruments (in terms of time, 
sensitivity of material, etc.) in the risk/benefit analysis.  Please attach copies or otherwise provide all non-standard 
instruments. 

Uploaded Protocol Summary Form 
11 
 
 
 
Instrument 
Variables Measured 
Baecke Physical Activity Questionnaire 
Initial assessment of sedentary status 
Polar Heart Rate monitor* 
heart rate during exercise training and protocol 
adherence 
Miflin-St Jeor prediction equation 
Estimate resting metabolic caloric needs 
Gulick anthropometric tape 
Waist circumference 
Seca 214 Portable Height Rod 
(Seca Corp., Hamburg, Germany). 
Height 
Tanita BF-350 monitor 
(Tanita UK Ltd., Middlesex, UK). 
Weight and body composition 
24 hr recall USDA Multiple-Pass Method 
Daily diet 
 
ECG 
Heart rate variability 
Clearblue Fertility Monitor Test Sticks 
Ovulation Date 
 
*Throughout all training sessions, patients will wear polar heart rate monitors that record HR throughout the session. These 
data will be uploaded to a secure Polar cloud-based server and evaluated after each session. This will assist in adherence and 
will provide rigorous documentation of training intensity levels. Anonymous Gmail email accounts will be set up for each 
participant with the help of their RA coach to make sure they do not include any identifying information, and these accounts 
will be tied to the Polar heart rate devices. Heart rate data for exercise session will be stored in the cloud identified only by 
this anonymous email account, which will only be used for the study for logging Polar data. Polar data is uploaded through 
either at-home wifi or via a cable link to a laptop and desktop computer. Subjects will be instructed to use these two 
methods to prevent association of their mobile phone number with their heart rate data in the cloud. 
 
 
Research Related Delay to Treatment  
 
Research involving participants who are in need of treatment invariably involves delay to care, and this delay is 
associated with risk. Scheduling of procedures must be carefully organized to minimize delay. Other delay must involve 
only that minimally necessary to accomplish the aims of the research while respecting subject well- being and safety. 
Describe the delay, by virtue of research participation in this study, before a participant can receive treatment of known 
efficacy or standard care routinely offered in the community. 
This is not a treatment study, so there is no delay to treatment that participants may need to receive. 
 
Clinical Treatment Alternatives  
 
Describe what other treatment or assessment options are available to subjects who do not participate in research. 
This is not a treatment study, so the alternative to participation is not to participate. 

Uploaded Protocol Summary Form 
12 
 
 
 
Risks/Discomforts/Inconveniences  
 
"Risk" is a broad term used to convey the potential for harm, burden, and inconvenience related to research 
participation. Use this section to provide a comprehensive description of foreseeable physical, psychological, social, 
interpersonal, and economic risks introduced by the research.  Include the source of the information.  Consider both the 
probability and magnitude of harm and its impact.  Describe the foreseeable harms associated with the research 
(untoward effects of a medication) and those related to delay to individualized treatment.  Include data from the 
literature, and local data, if available, on risk rates and subject experiences with research procedures. Describe 

Uploaded Protocol Summary Form 
13 
 
 
 
 
procedures in place to minimize risk. In general, please create a numbered list of risks/categories of risk, and in general 
put the list in the order of significance or level of risk, the most significant risks first followed by others. 
 
1. Submaximal Cardiopulmonary Test Risks 
 
There exists the possibility of certain changes occurring during the test. These include abnormal blood pressure; fainting; 
irregular, fast, or slow heart rhythm; and, in rare instances, heart attack, stroke, or death. Every effort will be made to 
minimize these risks by evaluation of preliminary information relating to the participant’s health and fitness and by 
careful observation during testing. Emergency equipment and trained personnel are available to deal with unusual 
situations that may arise. Since this is a submaximal exercise test, the risks associated are those typical of any physical 
activity, and are low. 
 
The submaximal cardiopulmonary exercise test will conducted in the Behavioral Medicine laboratory on the 16th floor of 
the Presbyterian Hospital Building. It will be administered by Vincenzo Lauriola, a Masters level exercise physiologist. 
According to the Handbook of Sports Medicine and the American College of Sports Medicine [6], participants at low risk 
can be supervised during this test by non-physicians without a physician being immediately available. Mr. Lauriola is 
certified at a level of basic life support (cardiopulmonary resuscitation [CPR]) and has automated external defibrillator 
(AED) training. The exercise testing facility also has a written medical emergency response plan with procedures and 
contact numbers and is equipped with an AED. 
 
 
2. Training Program Risks 
The risks associated with exercise training are those typical of any physical activity. All participants will have been 
carefully screened prior to the initiation of the exercise protocol to minimize the risk of adverse events. 
Participants will be required to present a note from a physician indicating medical clearance for exercise training. 
 
 
3. Blood Draw Risks 
Blood samples will be drawn by trained phlebotomists. 
During the blood draw, the participant may feel slight pain from the needle or experience some dizziness. She may also 
develop a temporary bruise where the needle was inserted. 
 
 
4. Peanut Consumption Risks 
Although we are currently unaware of any risks, there may be possible risks to the dietary intervention, such as 
previously unknown allergies. 
Subjects will be screened for known peanut allergies and monitored for signs of allergic reactions. 
 
Methods to Protect Confidentiality  
 
Describe the data management plan and the methods you will employ to protect subject privacy and the confidentiality 
of research data.  The section should detail how information will be collected, recorded, coded, stored, transmitted, and 
as applicable, shared with other investigators so as to minimize risks related to breach of confidentiality.  Confirm that 

Uploaded Protocol Summary Form 
14 
 
 
 
 
identifiers are removed, to the extent possible, from research data, and explain if there are links between subject identity 
and research data, or if the data is anonymous.  Also, indicate where the data is stored, who is responsible for its 
safekeeping, and who has access to subject identity and codes, if any, which cross-link research data and subject identity. 
Confirm that identifiable data is not collected, stored, or transmitted by mail, fax, on removable drives, laptops, or via the 
internet without proper protections, e.g. encryption. 
There are two areas in which safeguards to protect participants from undue risk require discussion: procedures used to 
obtain informed consent and those used to insure confidentiality of participants’ responses and findings on tests. In the 
consent form and in discussion with an investigator, participants will be advised fully of the procedures to be used, the 
amount of time required of them, the possible risks and benefits of the procedures, their right to refuse participation in 
the study without prejudice, their right to terminate participation at any moment without prejudice, and the name and 
telephone number of the Principal Investigator. In the informed consent form, participants are told that the information 
they provide and all findings will be kept strictly confidential, with access limited to the research staff and the possible 
exception of state or federal regulatory personnel. No one but designated project staff will have access to the master list 
linking participants’ names to subject identification numbers, and all information obtained will be coded. Data will be 
analyzed without reference to personal identifying information, and this information will be carefully protected within 
the database. All paper files will be kept in locked file cabinets. 
 
Direct Benefits to Subjects  
 
Describe only benefits to individual subjects that are likely to accrue during the study itself. Do not include subject 
compensation or treatment to be provided at the end of the study, as these do not figure into the IRB's risk benefit 
considerations. Do not describe diagnostic and evaluation components unless subjects receive clinical feedback. Do not 
describe the anticipated scientific benefits of the research.  Some studies offer no direct benefit to subjects. 
The cardiorespiratory benefits of moderate exercise are well known. Additionally, evidence suggests that peanut 
consumption is also cardioprotective; a substantial body of evidence exists that demonstrates the beneficial impact of 
nut consumption on cardiovascular disease outcomes and all-cause mortality. Any information that is important to the 
participant's health will, with the participant’s written permission, be transmitted to their physician. 

Uploaded Protocol Summary Form 
15 
 
 
 
 
 
 
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Participate in a Peanut and Exercise Research Study! 
Are you age 21-45? 
OVERWEIGHT but otherwise HEALTHY? 
You could earn up to $250 for completing the 14 week study! 
For more information, please call  
646-774-8950 
or email:  
psychiatry.bmed@cumc.columbia.edu 

Rese arc h  S u bject’s  C o nse nt  F o r m  C o ver  S heet  
 R a n d o mize d  C r oss o ver  Pil ot  St u d y:  E xercise  a n d  Pe a n ut  
C o ns u m pti o n   
PI  I R B#:  7 4 6 6  
N Y S PI  I R B #  7 4 6 6  
 
5/ 1 0/ 1 8  
O ver vie w  
Bel o w  is a s u m mar y of  t he st u d y i n w hic h  y o u  are as ke d t o partici pate.   T his  o utli ne  is mea nt  t o 
be  a g ui de  f or y o u  t o use  w hile  c o nsi deri n g t he st u d y a n d rea di n g t he c o nse nt  f or m.  It is n ot  
mea nt  t o re place t he c o ns e nt  f or m, w hic h  y o u  will  ha ve  t o si g n if y o u  d eci d e  t o partici pate  i n t he 
st u d y.  T he  c o nse nt  f or m c o ntai ns  detaile d  i nf or mati o n a b o ut t he st u d y a n d a b o ut  t he ris ks w hic h  
y o u  will  nee d  t o c o nsi der  bef ore  m a ki n g  y o ur  decisi o n.   Rea d  t he c o nse nt  f or m caref ull y a n d 
disc uss  it wit h  ot hers  bef ore  deci di n g  t o ta ke p art.   A n d  re me m ber t hat, e ve n if y o u  a gree t o 
partici pate,  y o u  ca n c h a n ge y o ur  mi n d  at a n y ti me. 
 
P ur p ose  of  St u d y  
T he  p ur p ose  of  t his st u d y is t o c o m pare t he effects  of  e x ercise a n d eati n g pea n uts  o n  
i nfla m mati o n a n d heart  rate v aria bilit y. 
 
P artici p ati o n  is V ol u nt ar y  
As  wit h  all researc h, t his is a v ol u ntar y  st u d y, a n d y o u  d o  n ot  ha v e  t o partici pate  if y o u  d o  n ot  
wa nt  t o. Y o u  ma y  st o p partici pati n g  at a n y ti me. 
 
Pr o ce d ures  
 
 Scree ni n g  a n d  Eli gi bilit y:   Y o u  will  be  as ke d q u esti o ns  a b o ut y o ur  h ealt h  a n d eati n g ha bits  
o ver  t he p h o ne  or  i n pers o n  t o see if y o u  will  be  a ble t o ta ke part  i n t he st u d y. 
 
 C o nse nt  A p p oi nt me nt:  Y o u  will  be  as ke d t o rea d a n d si g n t he i nf or me d c o nse nt  f or m as 
well  as c o m plete s o me f or ms a n d e val uati o ns.  If y o u  w o ul d  li ke t o partici pate  i n t he st u d y, 
y o u  will  be  as k e d t o a gree t o kee p  a c o nsta nt  b o d y  wei g ht  ( < ± 3 %), n ot  c ha n ge y o ur  eati n g 
ha bits  e x ce pt  f or w hat  is as ke d of  y o u , a n d k ee p  c urre nt  le vels of  p h ysic al  acti vit y,  e x ce pt  
f or t he st u d y i nter ve nti o ns, t hr o u g h o ut t he st u d y. Y o u  will  als o nee d  t o prese nt  a n ote  fr o m a 
p h ysicia n  i n dicati n g me dical  cleara nce f or e x ercis e trai ni n g. 
 
 E xercise  a n d  Diet  Tri al  Peri o d/ R u n -i n: Y o u  will  meet  wit h  researc h staff w h o  will  g ui de  
y o u  i n c o m pleti n g a t w o-wee k  trial peri o d.  Y o u  will  be  as ke d t o eat pita  c hi p s nac ks t wice 
per  da y  f or a w ee k , a n d t he n f or t he sec o n d wee k,  y o u  will  be  as k e d t o stret c h f o ur ti mes a 
wee k  f or 3 0  mi n utes  at t he g y m  w hile  w eari n g a h eart  rate m o nit or . 
 
 B aseli ne  E xercise  Test : If y o u  f oll o w t he i nstr ucti o ns d uri n g  t he trial peri o d , y o u  will  be  
sc he d ule d t o ta ke a baseli ne  e x ercise test t o deter mi ne  y o ur  fit ness le vel.  
 
 L a b or at or y  Testi n g  Sessi o ns:  F o ur  ti mes t hr o u g h o ut t he st u d y, y o u  will  be  sc he d ule d t o 
ha ve  y o ur  bl o o d  dra w n  a n d b o d y  metrics  m eas ure d  s uc h as hei g ht,  wei g ht,  b o d y  
c o m p ositi o n,  a n d waist  circ u mfere nce.  Resti n g  h eart  rate a n d ot h er  data  will  als o be  
c ollecte d.  
 
 Diet ar y  Ass ess me nt : Y o u  will  meet  wit h  researc h staff t o c o m plete a di etar y  ass ess me nt  i n 
w hic h  y o u  will  be  as ke d  q uesti o ns  a b o ut t he f o o ds y o u  t y picall y eat.  
 

 
 
N Y S PI  I R B # 7 4 6 6  
P a ge  2  of  8  
5/ 1 0/ 1 8  
 Pe a n ut  I nt a ke/ E xercise: Y o u  will  be  ra n d o ml y assi g ne d  t o o ne  of  t w o gr o u p s. I n t he 
pea n ut  gr o u p,  y o u  will  be  as ke d t o eat a b o ut a ha n df ul  of  r oaste d, u ns alte d  pea n uts  t wice a 
da y  f or 4  w ee ks.  I n t he e x ercise  gr o u p,  y o u  will  be  trai ne d a n d as ke d t o d o  hi g h  i nte nsit y 
i nter val trai ni n g f o ur ti mes a wee k  f or f o ur wee ks . After  t he f o ur wee ks  of  eit her eati n g 
pea n uts  or  e x ercisi n g,  y o u  will  be  aske d  t o st o p eati n g pea n uts  or  e x ercisi n g f or 4  wee ks.  
T he n  y o u  will  s witc h gr o u ps  t o t he pea n ut  gr o u p  if y o u  were  i n t he e x ercis e gr o u p  or  t o t he 
e x ercise gr o u p  if y o u  w ere  i n t he pea n ut  gr o u p.  
 
 
Ris ks  
T his  st u d y i ncl u des s o me ris ks a n d disc o mf orts  ( pl ease refer t o t he c o nse nt  f or m f or f urt her 
details  a n d e x pla nati o ns  of  t hese ris ks). T h e  ris ks ass ociate d  wit h  e x ercise trai ni n g are t h ose 
t y pical of  a n y p h ysical  acti vit y.  Ot h er  ris ks a n d dis c o mf ort  i ncl u de: disc o mf ort  d uri n g  bl o o d  
dra wi n g  a n d d uri n g  t he b ase li ne e x ercise test. E v er y  eff ort will  be  ma de  t o mi ni mize  t hese ris ks 
b y  e v al uati o n  of  bac k gr o u n d  i nf or mati o n relati n g t o t he partici pa nt’s  healt h  a n d fit ness a n d b y  
caref ul o bser vati o ns  d uri n g  testi n g. E mer ge nc y  e q ui p me nt  a n d trai ne d pers o n nel  are a vaila ble t o 
deal  wit h  u n us ual  sit uati o ns t hat ma y  arise.  
 
Be nefits   
T his  st u d y is n ot  desi g n e d  f or y o ur  direct  be nefit.  
 
T he  be nefits  of  m o derate  e x ercise are well  k n o w n.  A n y  i nf or mati o n t hat is i m p orta nt t o t he 
partici pa nt's  healt h  will,  wit h  t he partici pa nt’s  per missi o n,  be  tra ns mitte d t o t heir p h ysici a n.  
A d diti o nall y,  eati n g pea n uts  re g ul arl y ma y  re d uce t he ris k of  heart  disease.  
 
 
 
 
 
Y o u  ma y  c o ntact t he Pri n ci pal  I n vesti gat or, Ric har d  Sl oa n  at 6 4 6 -7 7 4 -8 9 4 0  wit h  a n y q u esti o ns.   
 
Please  rea d a n d si g n t he attac h e d c o nse nt  f or m f or a f ull descri pti o n  of  t he st u d y.  
 

 
 
NYSPI IRB #7466 
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Research Subject’s Consent Form 
Informed Consent for Participation in Research 
The Anti-Inflammatory Effects Exercise and Peanut Consumption 
PI IRB #7466 
 
Purpose of Study 
The purpose of this study is to examine and compare the effects of peanut consumption and 
aerobic exercise on heart health. You are being asked to participate because you are an 
overweight and sedentary, but otherwise healthy individual between the age of 21 and 45 years 
old.  
 
 
Voluntary 
Participation in this research study is voluntary. If you decide not to participate, or if you later 
decide to stop participating, you will not lose any benefits to which you are otherwise entitled.  A 
decision not to participate or withdraw your participation will not affect your current or future 
treatment at the New York State Psychiatric Institute or Columbia University.  
 
Alternatives to Participation  
This is not a treatment study. Information being collected is for research purposes only and is to 
learn more about the effects of dietary intervention and exercise on cardiovascular health, not 
about you. The alternative to participating is this study is not to participate.  
 
 
Procedures 
Eligibility During the Study 
Your eligibility is checked at multiple times during the early stages of the study through a series 
of evaluations, questionnaires, and tests done during study meetings. These include a Baecke 
Physical Activity Questionnaire, Dietary Questionnaire, questions about medical history, and 
submaximal cardiopulmonary tests. These help to determine whether or not you are able to 
continue. Also, in the event that you are unable to follow the procedures required, you may be 
withdrawn from the study. 
 
Consent Session 
If you agree to participate you will be asked to meet for less than an hour at the Division of 
Behavioral Medicine, Department of Psychiatry, on the 15th floor of the Columbia University 
Medical Center to read and sign the informed consent form and complete additional forms that 
will be needed for study protocol. You are required to present a note from a physician indicating 
medical clearance for high intensity aerobic exercise training. Your BMI will be estimated at this 
time. At this time, you must agree to maintain constant body weight (<±3%) and current levels of 
physical activity, except for the study interventions, throughout the protocol. If you meet the 
required eligibility criteria, study staff will schedule you for the next appointment.  
 
 
 
 

 
 
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Two Week Run-in 
You will then begin a two-week trial period, or run-in. You will meet at the Division of 
Behavioral Medicine to receive labeled pita chip snacks and will be asked to eat the snacks twice 
a day for one week. After one week, you will meet with the research assistant who will collect 
your labeled packets, determine if you did well enough to continue and provide instructions on 
how to proceed with the second phase of the run-in. You will be asked to engage in 30 minutes 
of stretching at home while wearing the Polar Heart Rate (HR) monitor, four times in 1 week. 
Coaches will provide you detailed instructions on how to perform the stretching and how to 
utilize the heart rate monitor. After each stretching session, you will upload the data from the 
heart rate monitor to a secure cloud-based server provided by Polar using an account that is 
anonymous and does not have any identifiable information contained within. Stretches will 
consist of arm circles, neck rotations, toe reach, gluteal stretches, lateral leg swings, Achilles 
stretch and ankle rolls. Your participation will be checked by gym attendance records and HR 
monitor data. If you sufficiently follow the instructions, you will be able to continue to the next 
part of the study. 
 
Baseline Exercise Test (CPET) 
At the Division of Behavioral Medicine, you will be guided to complete a cardiopulmonary 
exercise test which takes about 10 minutes. You will be asked to listen to an audiotape test 
instructions and commence stepping to the metronome beat at 15 steps per minute for a 2-minute 
period. The step rate then will be increased to 20 steps per minute for an additional 2 minutes. 
The test will continue to increase in speed until your heart rate reaches 80% of your maximal 
heart. The maximum test duration will be 10 minutes. 
 
Laboratory Session 1 
During the first lab session, your blood will be drawn and your height, weight, and body 
composition will be measured. Your heart rate will also be measured. You will be asked to wear 
ECG leads and respiration monitoring bands and rest quietly for 5 minutes, after which 20 
minutes of resting ECG and respiration data will be collected. After the blood draw, you will 
receive a light breakfast. Lab sessions will take about 1 hour and will be conducted at the 
facilities belonging to the Division of Behavioral Medicine on the 15th and 16th floors of the 
Columbia University Medical Center. 
 
Dietary Assessment 
For about 30 minutes, you will meet with the research assistant at the Division of Behavioral 
Medicine to assess your eating patterns. You will be guided in how to eat the peanuts without 
changing your diet too much. You must agree to avoid omega 3 supplements and nuts, and not 
eat excessive amounts of high fat fish like salmon (>8oz), flax seeds and chia seeds, soy 
(including soybean oil and canola oil) and food products that contain these (limit to <1 serving a 
day). You can otherwise maintain your regular diet. You will be asked questions about alcohol, 
caffeine, and cocoa consumption. 
 
4 Week Period: Peanut Diet 
You will be provided with labelled packets of peanuts weekly for four weeks and asked to eat 
two packets each day and record when and where you consume the peanuts. After each week you 
will return the empty packets and receive new ones for the next week from the research assistant. 

 
 
NYSPI IRB #7466 
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At any point in time during the 4 weeks, a research assistant may ask for details about when and 
where you ate the peanuts in the last 24 hours. 
 
 
4 Week Period: Exercise 
For four weeks, you will be asked to participate in 4 training sessions per week that last about 
20-30 minutes, with 24 hours of rest after each training day. Exercise sessions will take place 
either at the PlusOne Fitness Center at CUMC/NYPH, or at home on a Sunny Folding Climbing 
Stepper (Sunny Health & Fitness, Los Angeles) which will be delivered to you via UPS or FedEx, 
and retrieved by Behavioral Medicine staff at the end of the study, at no cost to. You are free to 
choose which method you wish to engage in, and will be asked to indicate your choice on this 
consent document. Each exercise session begins with a 3-minute low intensity warm-up, and 
then you will exercise aerobically as rapidly as you can for 20 seconds, aiming to reach 85% of 
your maximum heart rate. This 20 second period is followed by 40 seconds of low intensity 
exercise. You will be asked to complete 8 such intervals for sessions 1 and 2, 10 intervals for 
sessions 3 and 4, and 12 intervals for the remaining sessions. Research assistants will provide 
thorough training for you on how to perform the exercise and how to utilize the heart rate 
monitor. After each exercise session, you will upload the data from the heart rate monitor to a 
secure cloud-based server provided by Polar using an account that is anonymous and does not 
have any identifiable information contained within. Research assistants will be available 
throughout the week to answer questions about the protocol. 
 
4-week Washout Period:  
At the conclusion of the first 4-week period, you will be asked to resume your diet and activity 
as it was before the intervention. This means that you will be asked to discontinue eating peanuts 
or discontinue exercising for 4 weeks before continuing on to the second intervention, which will 
be peanut consumption if you were originally assigned to the exercise group, or exercise if you 
were originally assigned to the peanut group. 
 
Further Lab Sessions and CPETs  
After each 4-week period, including the washout period, you will be asked to complete a set of 
laboratory sessions in which your fasting blood will be drawn and a cardiopulmonary test like 
the first one will be given. Lab sessions will take about 1 hour and the cardiopulmonary tests will 
last at most 10 minutes. Both will be conducted at the same locations as were used previously. 
 
For women only: You will be asked to track and report your menstrual cycle once you enroll in 
the study. It is very important that we know when you ovulate during the month that you do your 
first exercise and laboratory. Therefore, we will give you a 7-day ovulation kit at the start of the 
study, and we will ask you to use this kit so that we can estimate your ovulation date. The 
ovulation test is a very quick and simple urine test that you will do at home. If for some reason 
you do not ovulate during this time, we may reschedule your lab and exercise test to the 
following month, and ask you to monitor your ovulation during that month as well. We will try 
to schedule each of the lab and exercise tests to be done following your ovulation date in that 
month. 
 
Risks and Inconveniences 

 
 
NYSPI IRB #7466 
Page 6 of 8 
5/10/18 
During the blood draw, you may feel slight pain from the needle or experience some dizziness. 
You may also develop a temporary bruise where the needle was inserted. If there is any difficulty 
in obtaining the blood or if there is some medical reason why we cannot perform the blood test, 
you will discontinue the study.  
 
There exists the possibility of certain changes occurring during the cardiopulmonary test. These 
include abnormal blood pressure; fainting; irregular, fast, or slow heart rhythm; and, in rare 
instances, heart attack, stroke, or death. Every effort will be made to minimize these risks by 
evaluation of preliminary information relating to the participant’s health and fitness and by 
careful observations during testing. Emergency equipment and trained personnel are available to 
deal with unusual situations that may arise. Since this is a submaximal exercise test, the risks 
associated are those typical of any physical activity, and are low. 
 
The risks associated with exercise training are those typical of any physical activity. All 
participants will have been carefully screened prior to the initiation of the exercise protocol to 
minimize the risk of adverse events.  Participants will be required to present a note from a 
physician indicating medical clearance for exercise training.  
 
Although we are currently unaware of any risks, there may be possible risks to the dietary 
intervention, such as previously unknown allergies. 
 
Benefits  
This study is not designed for your direct benefit. The primary benefit of this study will be to 
increase understanding of how dietary interventions and exercise influence cardiovascular health. 
The cardiorespiratory benefits of moderate exercise are well known. Any information that is 
important to the participant's health will, with the participant’s permission, be transmitted to their 
physician. 
 
Results 
While blood tests are sometimes done for clinical purposes, the kind of blood test you will have 
as part of this study is for research purposes only. This means that they are not designed to 
provide clinical information that might be helpful to you or your doctor and they may not show 
problems that would normally be found in a blood test ordered to evaluate a specific medical 
problem. If significant abnormalities are detected, you, or a physician whom you may designate, 
will be informed by a phone call. 
 
Confidentiality  
Your participation in this study will be confidential and if the results are published, your name 
will not be identified. Your records will be kept in locked files in locked offices and access will 
be allowed only to members of the research team or institutional personnel as part of a routine 
audit. Your name and other personal identifying information will be stored in an electronically 
secure database at Columbia University. Records will be available to research staff, and to 
Federal, State and Institutional regulatory personnel (who may review records as part of routine 
audits). The study could not be completed without this information. We will do everything we 
can to avoid disclosure about your participation in this study. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 

 
 
NYSPI IRB #7466 
Page 7 of 8 
5/10/18 
required by U.S. Law. This website will not include information that can identify you.  At 
most, the website will include a summary of the results. You can search this website at any 
time. 
 
Study Compensation  
You will receive $25 for each blood draw, $25 for each submaximal exercise test, and $50 if you 
achieve 85% adherence to both the exercise and dietary arms of the study. In total, you could 
receive compensation of $250. 
 
In Case of Injury 
If you believe that you have sustained an injury as a result of participating in a research study, 
you may contact the Principal Investigator, Dr. Richard Sloan, at (646) 774 - 8940 so that you 
can review the matter and identify the medical resources that may be available to you.    
 
In case of injury, New York State Psychiatric Institute will provide short term emergency 
medical treatment, which has been determined to be necessary by New York State Psychiatric 
Institute's doctors, and which is within the capability of New York State Psychiatric Institute to 
provide.  In addition, we will provide assistance in arranging follow up care in such instances. 
 
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do not 
provide compensation or payment for treatment of research related injuries.  However, you 
should be aware that you do not give up your legal right to seek such compensation through the 
court by participating in this research. 
 
Please be aware that: 
 
1. The New York State Psychiatric Institute, Columbia University and New York Presbyterian 
Hospital will furnish that emergency medical care determined to be necessary by the medical 
staff of this hospital. 
 
2.  You will be responsible for the cost of such care, either personally or through your medical 
insurance or other form of medical coverage. 
 
3.  No monetary compensation for wages lost as a result of injury will be paid to you by the New 
York State Psychiatric Institute, Columbia University or by New York Presbyterian Hospital. 
 
4.  By signing this consent form, you are not waiving any of your legal rights to seek 
compensation through the courts. 
 
Questions 
Research personnel will answer all current or future questions about the procedures and/or 
responses to the best of their ability.  If you have any questions about this study in the future, you 
may reach Dr. Richard Sloan at 646-774-8940. 
 
You will be notified of significant new findings that may relate to your willingness to continue to 
participate. 

 
 
NYSPI IRB #7466 
Page 8 of 8 
5/10/18 
 
If you have any questions about your rights as a research participant, want to provide feedback, 
or have a complaint, you may call the NYSPI Institutional Review Board (IRB). (An IRB is a 
committee that protects the rights of human subjects in research studies). You may call the IRB 
Main Office at (646)774-7155 during regular office hours.  
 
Documentation of Consent  
I voluntarily agree to participate in the research study described above. I have received a copy 
of this consent form.  I have been informed that if I believe I have sustained injury as a result of 
participating in a research study, I may contact the Principal Investigator, Dr. Richard Sloan at 
(646) 774-8940 so that I can review the matter. 
 
Please indicate which exercise program you wish to enroll in by checking the appropriate 
box: 
 
[  ] I wish to enroll in the PlusOne-based exercise program. 
 
[  ] I wish to enroll in the home-based exercise program. 
 
Print name: __________________________ 
 
Signed: ______________________________ 
Date: _______________________ 
 
I have discussed the proposed research with this participant including the risks, benefits, and 
alternatives to participation (including the alternative of not participating in the research).  The 
participant has had an opportunity to ask questions and in my opinion is capable of freely 
consenting to participate in this research.  
 
Print name: ___________________________ 
Person Designated to Obtain Consent  
 
Signed: _____________________________  
Date: _____________________ 

HIPAA Form A 
HIPAA Clinical Research Authorization for Sponsored Research 
Protocol Number:
Name of Study: 7KH$QWL,QIODPPDWRU\(IIHFWVRI([HUFLVHDQG3HDQXW
&RQVXPSWLRQ
Principal Investigator: Dr. Richard P. Sloan
For the purpose of the conduct of the above name study, I agree to permit Columbia University 
Medical Center, my doctors and my other health care providers (together “providers”), and Dr. 
Richard P. Sloan and his/her staff (together “Researchers”), to use and disclose health information 
about me as described below. 
1.
The health information that may be used and disclosed includes:
          . all information collected during the research described in the Informed Consent 
Form for the above-named study (“the research”); and
. health information in my medical records that is relevant to the Research. 
          . This may include medical history information that may be considered sensitive, 
including:
2.
The providers may disclose health information in my medical records to:
 . the Researchers;
. representatives of government agencies, review boards, and other persons who watch over the
VDIHW\HIILFDF\DQGFRQGXFWRIWKHUHVHDUFK
safety, effectiveness, and conduct of the research. 
3.
The researchers may use and share my health information:
    . among themselves and with other participating researchers to conduct the Research; 
    . representatives of government agencies, review boards, and other persons who watch over the  
safety, effectiveness, and conduct of research; and 
    . as permitted by the Informed Consent Form. 
4.
The Sponsor may use and share my health information as permitted by the Informed Consent
Form.
5.
Once my health information has been disclosed to a third party (e.g., a pharmaceutical
company participating in this Study), federal privacy laws may no longer protect it from
further disclosure.
6.
Please note that:
    . You do not have to sign this Authorization, but if you do not, you may not participate in the  
Research. 
          . You may change your mind and revoke (take back) this authorization at any time and for any  
reason.  To revoke this Authorization, you must write to: 

Dr. Richard P. Sloan 
Behavioral Medicine Program,  
Dept. of Psychiatry Columbia University Medical 
Center 622 West 168th Street, Suite 1540 
1<1<
    .  However, if you revoke this Authorization you will not be allowed to continue part in the 
Research. Also, even if you revoke this Authorization, the Researchers and the Sponsor may 
continue to use and disclose the information they have already collected as permitted by the 
Informed Consent Form 
          . While the Research is in progress, you may not be allowed to see your health information that is  
created or collected by Columbia University in the course of the Research.  After the Research is  
finished, however, you may be allowed to see this information. 
7.
This Authorization does not have an expiration (ending) date.
8.
You will be given a copy of this Authorization after you have signed it.
Printed Name of Subject: ________________________________________________________________ 
Signature of Subject or Legal Representative: ___________________________  Date: _______________ 
Relationship of Legal Representative to Subject (if applicable): _________________________________ 

Form #PP2: HIPAA Authorization for Research ϰ.ϭϰ.1ϰ 
New York State Psychiatric Institute (NYSPI) 
Authorization to Use or Disclose Health Information during a Research Study 
Protocol Number: 
Principal Investigator: 
Name of Study: 
Before researchers can use or share any identifiable health information (“Health Information”) about you as part of the 
above study (the “Research”), the New York State Psychiatric Institute (NYSPI) is required to obtain your authorization. You agree 
to allow the following individuals and entities to use and disclose Health Information about youas described below: 
x
New York State Psychiatric Institute (NYSPI), your doctors and other health care providers, if any, and
x
The Principal Investigator and his/her staff (together “Researchers”).   Researchers may include staff of NYSPI, the New York
State Office of Mental Health (OMH), Research Foundation for Mental Hygiene, Inc. (RFMH), and Columbia University (CU),
provided such staff is a part of the study, and
x
WƌŽǀŝĚĞƌƐŽĨƐĞƌǀŝĐĞƐĨŽƌƚŚĞZĞƐĞĂƌĐŚĂƚh͕Ez^W/ĂŶĚͬŽƌZ&D,͕ƐƵĐŚĂƐDZ/ŽƌWd͕ŽƌCentral Reference Laboratories
;EKI), iĨ indicated in the consent form.
1.
The Health Information that may be used andͬŽƌ disclosed for this Research includes:
All information collected during the Research as told to you in the Informed Consent Form.  
Health Information in your clinical research record which includes the results of physical exams, medical and 
psychiatric history, laboratory or diagnostic tests, or Health Information relating to a particular condition that is related  to 
the Research.
Additional information may include: 
2.
The Health Information listed above may be disclosed to:
Researchers and their staff at the following organizations involved with this Research: 
The Sponsor of the Research, 
and its agents and contractors (together, “Sponsor”); and  
Representatives of regulatory and government agencies, institutional review boards, representatives of the Researchers 
and their institutions to the level needed to carry out their responsibilities related to the conduct of the research.   
Private laboratories and other persons and organizations that analyze your health information in connection with 
this study 
Other (family members or significant others, study buddies, outside agencies etc.) Specify: 
3.
By giving permission to release your Health Information as described above, you understand that your Health
Information may be disclosed to individuals or entities which are not required to comply with the federal and state privacy laws
which govern the use and disclosure of personal Health Information by NYSPI.   This means that once your Health

Dr. Richard P. Sloan, Ph.D.
The Anti-Inflammatory Effects of Exercise and Peanut Consumption
✔
✔
✔
Columbia University Medical Center
✔

Form #PP2: HIPAA Authorization for Research ϰ.ϭ.1ϰ 
Information has been disclosed to a third party which does not have to follow these laws (e.g., a drug company or the Sponsor 
of the Research), it may no longer be protected under the HIPAA or NYS Mental Hygiene Law requirements but is subject to the 
terms of the consent form and may be subject to other state or federal privacy laws or regulations.  
4.
Please note that:
x
You do not have to sign this Authorization form, but if you do not, youŵĂǇ not be able to participate in the study or
receive study related care.  You may change your mind at any time and for any reason. If you do so, you may no
longer be allowed to participate in the study.  If you withdraw this Authorization the research staff and the Sponsor, if this
is sponsored research, may still use or disclose Health Information containing identifying information they already have
collected about you as needed to maintain the reliability of the research.  Any request to withdraw this Authorization
must be made in writing to (enter name and contact information below):
x
While the Research is going on, you may not be allowed to review the Health Information in your clinical research
record that has been created or collected by NYSPI.   When this research has been completed you may be allowed to see
this information.  If it is needed for your care, your Health Information will be given to you or your Doctor.
5.
This Authorization does not have an end date.
6.
You will be given a copy of this form after you have signed it.
I agree to the use and disclosure of Health Information about me as described above: 
__________________________________________                _____________________ 
Signature of ParƚŝĐŝƉĂŶƚ/ Legal Representative    
Date 
______________________________________ 
Printed Name of ParƚŝĐŝƉĂŶƚ 
______________________________________ 
ZĞůĂƚŝŽŶƐŚŝƉŽĨ>ĞŐĂůZĞƉƌĞƐĞŶƚĂƚŝǀĞƚŽWĂƌƚŝĐŝƉĂŶƚ;ŝĨĂƉƉůŝĐĂďůĞͿ 
We also ask you or your legal representative to initial the statements below: 
I have received a copy of the NYSPI/OMH Notice of Privacy Practices. 
Dr. Richard Sloan, Ph.D. 622 West 168th Street, PH Suite 1540, New York, NY 10032
Tel: 646-774-8940 Email: rps7@cumc.columbia.edu

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