Exploring the Role of Peanuts in Enhancing Healthy Weight Gain in Athletic Individuals
Phase: NA
Conditions: Weight Gain
Sponsor: Virginia Polytechnic Institute and State University

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INSTRUCTIONS: 
● Use this “TEMPLATE PROTOCOL (HRP-503)” to prepare a study protocol 
outlining your research plan.  
● Depending on the nature of your study, some major sections might not be 
applicable to your research. If so, simply mark as “N/A.” For example, a simple 
survey might have many sections with “N/A.”  For subsections (e.g., 1.x or 8.x) 
you can mark as “N/A”if you are certain that the subsection is not applicable. 
● Once the IRB/HRPP approves your submission, your latest approved version of 
the protocol will be stored in the IRB Protocol Management online system.  
● If your research plan changes and you need to modify the protocol, please submit 
an amendment to Protocol Management with the requested modifications. 
Download your current protocol from Protocol Management and indicate the 
changes/revisions using the track changes feature in order to make review of the 
modifications easier to follow. If you are unable to use track changes, please 
create a new paragraph wherever you need to make a change, and indicate 
“Amendment: Date” before making a change to any section. Protocol 
management will store the older versions of your protocol if the IRB or HRPP 
staff need to compare them during the review. 
 
PROTOCOL TITLE:  
Include the full protocol title.  
 
Exploring the Role of Peanuts in Enhancing Healthy Weight Gain in Athletic 
Individuals 
 
PROTOCOL NUMBER:   
Include the number assigned in Protocol Management (verify this has been added 
before submitting protocol to HRPP).  
 
 
21-561 
 
PRINCIPAL INVESTIGATOR: 
Full Name and Degrees: Dawnine Enette Larson-Meyer 
Department: Human Nutrition, Foods, and Exercise 
Telephone Number: 540-231-1025 
Email Address: enette@vt.edu 
 
FUNDING: 
 
Sponsor(s): Peanut Institute 
 
Funded already or in the proposal phase?: Recently Funded 
Is Virginia Tech the primary awardee or the coordinating center of this grant or 
contract? If not, list the primary institution: Virginia Tech 
 

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VERSION NUMBER/DATE:  
Include the version number and date of this protocol. Versions should start at 1.0. 
 
Version 6.0 
 
REVISION HISTORY:  
Use this table to keep track of changes. Add more rows as needed. 
 
Revision 
# 
Version Date 
Brief Summary of Changes  
(i.e., the different sections) 
Consent 
Change? 
1 
28 June, 2021 
Requested additional or clarifying details 
added to sections 8 (most), 9.4, 10.0, 12.2 and 
12.3, 15.4, 21.0, 24.1 and 25.2 
Yes 
2 
25 July, 2021 
Requested additional details added to sections 
7.3, 8.3, 9 and 15.4. Typos corrected. DOB and 
a few edits made to consent, advertisement 
flyer and several study forms.  
Yes 
3 
28 Sept, 2021 
Completed changes suggested by Board 
specifically related to the addition of coronary 
artery disease as an exclusion factor (section 
12) and clarification on the health history 
questionnaire (section 8.1 and 20), GPS 
(section 8.1) and pregnancy test with the DXA 
(Table in section 8 and in consent. Clarified 
payment info (discussed on IRB Call in section 
15.4; Made requested changes to consent 
(which included carefully reading over for 
clarity and typos and editing factors related to 
the above); Made required changes to 
recruitment flyer; Added the doctoral student 
(previously listed as TBA) who will be in 
charge of the protocol (A Sanchez). 
Yes 
4 
Nov 1, 2021 
We have made minor editorial and logistic 
questions to the protocol and consent that 
includes: a) minor  changes in screening (we 
will use HIPA compliant zoom vs telephone 
when possible) and the screening form 
(updated form uploaded); b) minor changes to 
the snack items offered (complete list 
uploaded), walking economy speed, VO2max 
protocol, and resistance training exercises; and 
c) inserted language that participants would not 
Yes 

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be informed of the macronutrient composition 
of the two snack groups.  We also include 
new/updated participant instructions  for use of 
the smartwatch, CGM and 24 h urine 
collection.  
5 
25 January 
We added information about the Eating 
Attitudes Questionnaire that will be used to 
help screen for eating disorders and disordered 
eating to sections 12.2 and 19.5. We uploaded 
the referral sheet that will be provided to 
anyone who scores higher than a 20 on this 
test.  
Yes 
6 
7 April 
We added abnormal serum lipids as an 
exclusion criterion (section 12.0, page 26). We 
added an additional questionnaire at baseline to 
evaluate vitamin D status as a baseline health 
outcome and a study exit survey at study 
conclusion (Table 1 and section 8.2). We 
clarified that we will also measure iodine 
concentration in the urine samples to help 
interpret thyroid and other hormone 
concentrations at baseline and study end. We 
would also like to increase our potential sample 
size to 40 from 32 to account for a possibility 
of drop outs and ensure we have a complete 
sample of 32 participants; we still plan on 
recruiting as close to half men and half women 
as possible with a balance between our two 
intervention groups. We also added an exit 
survey. We uploaded the Vitamin D Food 
Frequency and Lifestyle Questionnaire and the 
Exit Survey.   
Yes 
 

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Table of Contents 
1.0 
Study Summary 
5 
2.0 
Objectives 
6 
3.0 
Background 
6 
4.0 
Study Endpoints 
9 
5.0 
Study Design and Statistical Analysis Plan 
10 
6.0 
Setting 
11 
7.0 
Study Intervention(s)/Investigational Agent(s) 
11 
8.0 
Procedures Involved 
13 
9.0 
Data and Specimen Long Term Storage and Use 
23 
10.0 Sharing of Results with Subjects 
25 
11.0 Study Timelines 
25 
12.0 Inclusion and Exclusion Criteria 
26 
13.0 Vulnerable Populations 
27 
14.0 Number of Subjects 
28 
15.0 Recruitment Methods 
29 
16.0 Withdrawal of Subjects 
30 
17.0 Risks to Subjects 
31 
18.0 Potential Benefits to Subjects 
34 
19.0 Data Management and Confidentiality 
35 
20.0 Provisions to Protect the Privacy Interests of Subjects 
37 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
38 
22.0 Compensation for Research Related Injury 
40 
23.0 Economic Burden to Subjects 
40 
24.0 Consent Process 
40 
25.0 Process to Document Consent in Writing 
44 
26.0 Resources Available 
45 
27.0 Multi-Site Research 
46 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Exploring the Role of Peanuts in Enhancing Healthy Weight 
Gain in Athletic Individuals 
Study Design 
Randomly Assigned Intervention Study 
Primary Objective 
Determine the efficacy of the standard hypercaloric sports 
performance diet (500 kcal surplus energy, adequate protein 
and carbohydrate, judicious fat) and weight training regimen 
with excess calories from peanut foods or high-carbohydrate 
snack foods on weight and lean mass gains over 10 weeks in 
athletic men and women desiring weight gain. 
Secondary 
Objective(s) 
Secondary Aim: Evaluate the ease and acceptability of whole 
peanuts, peanut butter and peanut-based healthy snacks 
relative to high-carbohydrate snacks as part of the standard 
hypercaloric regimen. 
Exploratory Aim: Examine the effect of potential adaptive 
factors (increased resting metabolism, decreased appetite) 
and individual characteristics (sex, age, training history, 
somatotype) on weight and lean mass gains. 
Study Population 
Athletic and military men and women who desire weight 
gain primarily as lean mass to improve performance and/or 
effectiveness in sport/military endeavors. 
Sample Size 
32 (16 men and 16 women) 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Men and women will be randomly assigned to a peanut 
intervention or control group (8 men and 8 women per 
group); Each group will undergo a 10-wk diet and weight 
training regimen designed to promote healthy weight gain. 
Study Duration for 
Individual 
Participants 
12 to 13 weeks including screening, baseline testing, the 10-
week intervention and post-testing  
Acronyms and 
Definitions  
DXA, Dual-Energy X-ray Absorptiometry; TSH, thyroid-
stimulating hormone; CBC, complete blood count; RMR, 
resting metabolic rate; REE, resting energy expenditure; 
VO2 max, maximal oxygen uptake during exercise, also 
known as aerobic capacity; Reps; repetitions; CGM, 
continuous glucose monitoring; ISAK, International 
Standards for Anthropometric Assessment; ACSM, 
American College of Sports Medicine; IUSCA, International 
Universities Strength and Conditioning Association; HIP 
Laboratory, Human Integrated Physiology Laboratory; NEM 
Laboratory, Nutrition and Exercise Metabolism Laboratory  
 
 
 
 
 

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2.0 
Objectives 
2.1 Describe the purpose, specific aims, or objectives of this study: 
1) Determine the efficacy of the standard hypercaloric sports performance diet 
(500 kcal surplus energy, adequate protein and carbohydrate, judicious fat) and 
resistance training regimen with excess calories from peanut foods or high-
carbohydrate snack foods on weight and lean mass gains over a 10-wk period in 
athletic men and women desiring weight gain. 
2) Evaluate the ease and acceptability of whole peanuts, peanut butter and peanut-
based healthy snacks relative to high-carbohydrate snacks as part of the standard 
hypercaloric regimen.  
3) Explore the effect of potential adaptive factors (increased resting metabolism, 
decreased appetite) and individual characteristics (sex, age, training history, 
somatotype) on weight and lean mass gains.  
 
2.2 State the hypotheses to be tested:  
The standard hypercaloric sports performance diet (500 kcal surplus 
energy, adequate protein and carbohydrate, judicious fat) and resistance 
training regimen with excess calories from peanut foods or high-
carbohydrate snack foods will result in an average weight gain of 1/2 
pound/week in both men and women, with the majority of that gain as lean 
(fat-free mass) mass.  
Weight gain will be more efficient when the excess calories are from 
peanut foods (compared to control, high-carbohydrate foods) which will 
be better accepted than the control snacks. 
 
3.0 
Background 
3.1 Summarize the relevant prior research on this topic and gaps in current 
knowledge within the field of study: 
 
Many athletes and military personnel desire weight gain primarily as lean mass to 
improve performance and effectiveness in sport/military endeavors.  While much is 
known about the energy restriction required to reduce body fat, little is understood about 
energy and macro-nutrients needed to promote healthy gains in body weight and lean 
mass. Typically, athletes are encouraged to increase energy intake by 400-500 kcal/day 
with an emphasis on adequate protein (1.2- 2.0 g protein per kg body weight for athletes), 
adequate carbohydrate (Butterfield, Kleiner et al. 1995, Williams, Branch et al. 2017), 
and judicious inclusion of healthy fat-containing, energy dense foods (e.g., peanut butter, 
peanuts, nuts, avocado, and dried fruit) (Grandjean 1999, Williams, Branch et al. 2017). 
While it is well recognized that greater gains in body mass are possible in the first year of 

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intense resistance training, subsequent gains taper off. Lemon, for example, estimated 
that body mass may increase by as much as 20% in young male body builders and 
football players in the first year of training, with subsequent yearly gains of only 1 to 3% 
(Butterfield, Kleiner et al. 1995). In general, however, gaining 1/2 to 1 lb/wk is the 
recommended goal (Williams, Branch et al. 2017).   
 
Previous Studies on Weight Gain. Despite its importance, healthy weight gain is 
an often-ignored area of sports and human performance nutrition. Surprisingly little 
research has been conducted to either help establish guidelines for healthy weight gain or 
validate the typical aforementioned text book guidelines. In fact, initial weight gain 
guidelines were established using estimates of the energy required to promote muscle 
tissue accretion (Williams, Branch et al. 2017) from studies conducted in malnourished 
(Spady, Payne et al. 1976) and experimentally overfed sedentary subjects (Forbes, Brown 
et al. 1986). Muscle tissue itself is only~700-800 kcal/lb due to its high water content 
(~75% water) with only ~20% of weight as protein (Slater, Dieter et al. 2019). The 
additional 500 kcal/day (Butterfield, Kleiner et al. 1995, Williams, Branch et al. 2017, 
Slater, Dieter et al. 2019) was established based on estimates of the National Research 
Council that ~5 kcal are needed to support accretion of 1 gram of tissue during growth 
(Williams, Branch et al. 2017), which corresponds to estimates from studies of 
malnourished and overfed participants (Spady, Payne et al. 1976, Forbes, Brown et al. 
1986).    
             Although methods of weight gain in athletes were heavily discussed in the mid to 
late 90’s (Butterfield, Kleiner et al. 1995, Grandjean 1999), few studies have been 
conducted over the past 20 years, other than those specifically focusing on protein intake 
and timing on acute muscle protein synthesis (Phillips and Van Loon 2011). In one of the 
few studies conducted, Bartels and colleagues (Bartels, Lamb et al. 1989) found that the 
addition of 500 extra kcal/day during 9 weeks of heavy resistance training resulted in 
approximately ½ lb increase in lean mass/wk with no corresponding increase in body fat 
percentage in 12 male weight trainers. Body weight increases did not differ whether the 
hypercaloric diet was 45 versus 65% carbohydrate. Another semi-controlled study of 
Kreider et al. (Kreider, Klesges et al. 1996) examined whether supplementing the diet 
with one of two commercially-available weight gain powders for 28 days compared to a 
maltodextrin placebo influenced lean tissue accretion.  Carbohydrate ingestion alone 
promoted a non-significant increase in lean weight of 1.47 lb (670 g) with increase in 
body fat weight; while ingestion of one commercial powder produced identical increases 
(665 g) but also an increase in body fat. The other powder promoted a significant increase 
of 1.56 lb (707 g) predominately as lean tissue. A more recent study by Garthe et al 
(Garthe, Raastad et al. 2011) examined the effect of nutritional counselling (designed to 
create a 500 kcal/day surplus) compared to ad libitum dietary intake on changes in body 
composition during an 8-12 week focused resistance training period in 21 elite 
Norwegian athletes (including 4 women). Individually-prescribed hypercaloric meal 
plans and counseling resulted in successful short and long-term gains in total body and 
lean mass. To our knowledge, no studies have evaluated intentional weight gain in active 
women (who may also desire weight gain (Minnick, Raffoul et al. 2020)) or focused on 
the health implications of such gain in athletes. 
 
Benefit of Peanuts and Peanut Products in Healthy Weight Gain. Research and 
observations by sports dietitians suggest that active individuals interested in weight gain 

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often rely on commercially-available powders (Kreider, Klesges et al. 1996), energy bars 
and other high-protein specialized products as a source of additional calories (Minnick, 
Raffoul et al. 2020) during weight gain attempts. These food items, however, are 
considered ultra-processed foods (Pagliai, Dinu et al. 2021). A growing body of evidence 
links ultra-processed food consumption to adverse health outcomes, including increased 
risk of cardio-metabolic disease, stroke and depression (Pagliai, Dinu et al. 2021). Given 
the increased interest in the health benefits of whole-food and plant-based diets (and the 
combination of the two), peanuts are an ideal source of high-quality plant-based protein 
for consumers interested in weight/lean mass gain. Peanut butter, peanuts, and nuts are 
typically suggested foods to include in healthy weight gaining meal plans (Grandjean 
1999) because they are both nutrient- and energy-dense. Peanuts contain nutritionally 
significant quantities of potassium, magnesium, copper, iron, and fiber (Kholief 1987). 
Peanut protein provides substantial quantities of most amino acids, but it is low in 
methionine and tryptophan, and particularly high in arginine relative to other proteins. 
Additional methionine and tryptophan are easily obtained by combining peanuts with 
oats, rice, wheat and nuts. The high arginine content along with high concentrations of 
phytonutrients may offer health benefits and reduce risk of chronic and inflammatory 
diseases. Arginine in particular is a precursor to the potent vasodilator, nitric oxide. 
External nitric oxide has the potential to lower blood pressure and promote exercise 
efficiency (Jones, Vanhatalo et al. 2021).  Additionally, peanuts and peanut butter are 
affordable, readily available, and add flavor and versatility to the diet, making peanuts an 
ideal food to incorporate into a healthy weight gain meal plan.  
 
3.2 Describe any relevant preliminary data: 
Dr. Davy has previously completed a similar diet-induced weight gain 
protocol in non-athletes; This protocol overfed 14 male (Gentile, Orr et al. 
2007) and 3 female (unpublished data) participants ~1000 calories per day 
over baseline requirements using commercially-available food/beverages 
as the source of excess daily energy. 
 
3.3 Based on the existing literature, provide the scientific or scholarly 
rationale for and significance of your research and how will it add to 
existing knowledge: 
With increased prevalence of overweight and obesity in the U.S and 
worldwide, emphasis on understanding healthy weight gain in both the 
general population and among athletes and military personnel has been 
largely ignored. However, a recent survey of close to 977,000 Canadian 
adults, aged 17-32 years, found that ~23% of men and 6% of women 
reported attempting to gain weight in the past 12 months (Minnick, 
Raffoul et al. 2020). In athletes (Garthe and Maughan 2018) and military 
personnel (Bukhari, DiChiara et al. 2021), desire to gain weight is a top 
reason reported for supplement use. Attempts to gain weight included 
eating more overall and eating more protein (Minnick, Raffoul et al. 2020) 
through consumption of foods that are often ultra-processed, and likely to 

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have negative health effects. Previous studies by Dr. Davy’s group found 
that weight gain of 5 kg using such foods increased systolic and diastolic 
blood pressure even in those who were relatively fit (Gentile, Orr et al. 
2007).  The proposed study would serve as an important first step in 
helping understand the gaps in knowledge related to healthy weight gain. 
Findings would be of interest to sports and military dietitians and would 
be expected to lead to better understanding of the energy surplus needed to 
overcome metabolic adaptation and develop more targeted weight 
prescriptions. Results would inform the design of more effective weight 
gain meal plans, not only in athletes and military personnel, but also in 
older individuals and in clinical populations where promotion of weight 
gain is advocated. Future trials based on findings of the proposed study 
will likely explore benefits of peanut products in healthy weight in a 
variety of populations 
 
4.0 
Study Endpoints 
4.1 Describe the primary and secondary study endpoints. See links below for 
discussion of study endpoints and how they may differ from study 
objectives. These are most common in clinical trials but are sometimes 
applicable to other types of biomedical research, as well as social, 
behavioral, or educational research. See link below for a discussion. 
https://docs.google.com/document/d/1Wocz7K7a0hCQJPPO_khh5l1
SQQjhGDDGHzcOPRHR5Tw/edit?usp=sharing  
 
Primary Endpoints 
Change in Body Weight 
Change in Fat-Free Mass 
Change in Fat Mass (via DXA) 
Starting and Ending Body Fat Percentage (via DXA) 
Change in Sum of Skinfolds  
Change in Body Circumferences/Girth 
Absolute Energy Intake and Change in Energy Intake 
24-h Glucose 
Snack Susceptibility and Ease of Consumption Rating 
Secondary Endpoints 
Change in Resting Metabolic Rate/Resting Energy Expenditure 
Change in Hormone and Metabolic Markers in Blood including testosterone (free 
& total), growth hormone, insulin-like growth factor, leptin, insulin, thyroid 
hormones, cortisol and ghrelin and urinary creatinine and urinary iodine 
Change in Strength (all muscle groups) 
Change in Aerobic Fitness  
Change in Walking Economy 

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Change in and absolute values of Health Outcomes (blood pressure, serum 
cholesterol, fasting and 24-hour glucose concentration, and hydration status) 
Change in Dietary Patterns 
Change in Physical Activity and Structured Exercise  
Change in Appetite 
Baseline vitamin D intake and status and change in serum vitamin D 
 
 
4.2 Describe any primary or secondary safety endpoints. These should be 
included for all studies that are greater than minimal risk. (Minimal risk: 
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.): 
 
Safety Endpoints  
Excess weight gain (>1.5 lb/wk)  
Change in and absolute values for several health outcomes including blood 
pressure, serum cholesterol, fasting and 24-hour glucose concentration and 
hydration status 
Excessive muscle soreness and/or pain 
Muscle of joint injury 
General fatigue 
 
5.0 
Study Design and Statistical Analysis Plan 
5.1 Describe the basic study design/approach (e.g., qualitative study using five 
focus groups of first year students to describe assimilation into the 
university community; randomized controlled trial of a behavioral change 
intervention to increase dietary intake of whole grains; pre- post-test 
evaluation of new pedagogical techniques to improve adult literacy): 
 
This study is a randomly assigned intervention study that will evaluate the 
effect of a 10-wk diet and exercise regimen designed to promote healthy 
weight gain in athletes and military personnel (who desire weight gain).  
This will include increasing energy intake by 500 additional kcal/day (above 
weight maintenance diet) through daily provision of either peanut-based 
whole foods/snacks (peanut group) or a similar, high-carbohydrate, peanut-
free snack (control group) along with a supervised resistance training 
regimen.   
 
 
 

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5.2 Describe corresponding data analysis plan/approach (e.g., content analysis 
of focus group transcripts; descriptive analysis followed by linear 
regression modeling; nonparametric analysis of pre- and post-test 
measures): 
 
Data will be analyzed using IBM SPSS statistics software. Repeated measures ANOVA 
will be used to assess changes in dependent variables including participant body weight, 
body composition and anthropometric variables by group and across time (Aim 1). 
Student t-tests and simple and partial correlation statistics (Pearson Product or Spearman 
Rank) will be used to evaluate the magnitude of change in body weight/lean mass 
according to participant characteristics (sex, age, training status, somatotype) and 
significant adaptive changes in thermogenesis and appetite (Aim 3). Descriptive statistic 
methodologies will be applied to evaluate the ease and acceptability of peanut foods in 
the weight gain meal plan (Aim 2). The significance level will be set a priori at p<0.05 
 
 
6.0 
Setting 
6.1 Describe the sites or locations where your research team will conduct the 
research.  Consider each of the items listed below: 
● 
Identify where your research team will identify and recruit potential 
subjects. 
● 
Identify where the team will perform the research procedures. 
● 
Describe the composition and involvement of any community 
advisory board(s). 
● 
For research conducted in other locations, describe: 
o 
Site-specific regulations or customs affecting the research at 
those locations. 
o 
Local scientific and ethical review structure at those locations.  
Examples include work in other cultures or ethnic groups 
(within or outside of the U.S.) and work with churches. The 
HRPP will provide additional guidance for international 
research. 
 
 
The research will be conducted at Virginia Tech. Our research team will identify and 
recruit potential research participants and also perform the research procedures in  the 
Human Integrative Physiology (HIP) Laboratory in the Garvin Innovation Building or the 
Nutrition and Exercise Metabolism (NEM) Laboratory in the research building located on 
2270 Kraft Drive in the CRC.   
 
 
7.0 
Study Intervention(s)/Investigational Agent(s) 

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7.1 Describe the study interventions (including behavioral interventions) and/or 
investigational agents (e.g., drugs or devices) to be used in this study.  Consider 
each of the items listed below:  
● 
Drug/Device Handling: If the research involves drugs or devices, 
describe your plans to store, handle, and administer the drugs or 
devices so that they will be used only on subjects, and only by 
authorized investigators. 
● 
Describe whether any of the following will be used: microwaves, X-
rays, DEXA scans, general anesthesia, or sedation 
● 
If control of the drugs or devices used in this protocol will be 
accomplished by following an established, approved organizational 
SOP (e.g., Research Pharmacy SOP for the Control of 
Investigational Drugs, etc.), please reference the SOP in this section. 
 
 
The Research does not involve administration of drugs.  The research does 
involve use of Dual-energy x-ray absorptiometry (DXA/DEXA) scans that will 
be performed at 4 timepoints during the study 
 
 
7.2 List the name of all drugs (including any vitamins, supplements, herbs, or 
nicotine) to be used in the study.  Indicate whether they have FDA 
approval, and list any limitations for their use:  
 
N/A 
 
7.3 List all devices, how they will be used, their purpose in the study, and if 
they will be used in a manner consistent with their approved uses. If they 
will be used in ways that are not yet FDA approved, indicate whether they 
need an IDE or a determination that they are exempt from the IDE 
Determination. If a determination of significant risk or non-significant risk 
is needed for any of the devices, include the researcher’s recommendation 
for each of those devices:  
 
The medical devices/equipment used in this study include the DXA and 
the CGM sensors.  
The DXA will be used to assess total body composition. Both devices are 
FDA approved and the research will involve employment of these devices 
for approved uses. Scans will be performed only by members of the 
research staff who are trained and certified bone densitometry 

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technologists (CBDT) through the International Society of Clinical 
Densitometry.  
The CGM will be used only for research and not diagnostic purposes for 
the intended FDA approved intent of monitoring blood glucose 
concentration over several days. Prescriptions are not required to obtain 
CGM devices from Abbott Laboratories (FreeStyle Libre) if they are to be 
used for research purposes.  Dr. Davy has experience using CGM for 
research purposes as part of ongoing collaborative research projects.  
 
7.4 If the drug is investigational (has an IND) or the device has an IDE or a 
claim of abbreviated IDE (non-significant risk device), include the 
following information: 
● 
Identify the holder of the IND/IDE/abbreviated IDE. 
● 
Explain procedures followed to comply with sponsor requirements 
for FDA regulated research for the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
 
 
N/A 
 
 
 
8.0 
Procedures Involved 
8.1 Describe and explain the study design: 
Sixteen men and sixteen women between the ages of 18 and 40 will be randomly 
assigned to the peanut intervention or control group (8 men/8 women/group).  A 
computer program with a random number generator will be used by the study coordinator 
to assign male participants and female participants to the peanut or control group (i.e., 
each sex will be separately randomized).  
 
As outlined in the table, eligible participants will undergo a 10-wk diet and 
training regimen designed to promote healthy weight gain.  This will include increasing 
energy intake by 500 additional kcal/day (above their typical weight maintenance diet 
and accounting for energy requirements of resistance training) through provision of 
peanut-based whole foods/snacks or high-carbohydrate containing control snacks along 

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with a supervised rigorous resistance training regimen designed to promote muscle 
hypertrophy. After providing informed consent, participants will be randomly assigned to 
the peanut or control group based on sex.  Outcome data will include assessment of body 
mass, total and regional body composition via DXA and body anthropometrics, skinfolds 
and somatotyping using the International Standards for Anthropometric Assessment 
(ISAK) (Stewart, Marfell-Jones et al. 2011) along with measures of resting metabolic rate 
(RMR), circulating hormones and serum/plasma biomarkers. The latter includes 
measurement of potentially important hormones/ biomarkers of anabolism, stress, 
overfeeding, and cardiometabolic health. Compliance to the nutrition and exercise 
regimen will be evaluated at regular intervals and include collection of 3-day food 
records (performed at baseline and 3-days prior to each assessment point) and physical 
activity data collected by digital technology (Garmin Vena SQ smart watch and My PT 
Hub app).     
 
Dietary Intervention. The peanut group will be provided with a variety of whole 
and laboratory-prepared peanut-containing snacks to meet their daily excess energy. 
Examples of snacks include peanut butter  cookies, trail mix, peanut butter banana 
smoothies, and peanut butter and fruit jam sandwiches that provide 500 kcal (~15 g of 
protein). The control group will be provided similar 500 kcal high carbohydrate 
containing snacks (e.g., blueberry muffins, trail mix with chocolate chips and dried fruit, 
fruit smoothie, etc). A complete list of these snacks is uploaded as supplemental files and 
will be shown to participants. These snacks will be prepared in the research kitchen in 
Wallace Hall (Dr. Davy's Laboratory). Participants will be encouraged to consume snacks 
within an hour of resistance training and/or before bed (Phillips and Van Loon 2011). 
Participants will also undergo weekly assessments to ensure compliance and adequate 
progress with excess energy that will be adjusted upward with weight gain to avoid the 
potential effects of acute energy imbalance due to total body/lean mass gain, and help 
ensure adequate (~0.5 pound/week) but not excessive (>1.5 pounds/week) weight gain. 
Dr. Davy has previously completed a similar diet-induced weight gain protocol in non-
athletes; This protocol overfed 14 male (Gentile, Orr et al. 2007) and 3 female 
(unpublished data) participants ~1000 calories per day over baseline requirements using 
commercially-available food/beverages as the source of excess daily energy. Both 
investigators are research dietitians and have extensive experience with assessment of 
energy balance and with partial- and fully-controlled feeding trials.   
 
Resistance Training. Participants will undergo rigorous resistance training three 
days/week in the NEM laboratory under close supervision. The following will be 
performed with weight machines (Nautilus) and free weights: leg press, squat, leg 
extension, leg flexion, toe raise, lat-pull down, dead lift, shoulder press, bench press, 
bicep curl, triceps extension and abdominal twist/crunch. The overall goal will be to have 
participants perform 10 sets of exercises that work the major muscle groups each week in 
accordance with a recently published position stand of the International Universities 
Strength and Conditioning Association (IUSCA) (Schoenfeld et al 2021) with slightly 
different set of exercises performed on each of the three days. Participants will begin with 
light to moderate resistance for 8-15 repetitions, after which resistance will be gradually 
increased in the next 5 workouts. After that, three to five sets of each exercise will be 
completed using modified methodology of Bartels et al (Kreider, Klesges et al. 1996) 
(previously shown to effectively promote weight gain) in accordance with the latest 

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guidelines for promoting muscle hypertrophy (Schoenfeld et al 2021). . Resistance will 
be adjusted upward after 8 repetitions are fully executed using proper technique. 
Participants engaged in a sport or military training activity will be instructed to maintain 
their normal training throughout the study.  
Table 1. Overview of Data Collection 
Overview of Data Collection 
 
 
 
 
 
Baseline 
3 wk 
7 wk 11 wk 
Body Mass (weight) 
x 
x 
x 
x 
Body Composition by DXA and spot urine sample; 
Pregnancy test by urine in female participants 
x 
x 
x 
x 
Skinfolds & circumferences 
x 
 
 
x 
Resting metabolic rate-RMR 
x 
x 
 
x 
Blood via venipuncture and Urine vis 24-hr collection 
CBC and TSH 
x 
 
 
 
Testosterone (free &total) 
x 
x 
x 
x 
Growth Hormone 
x 
x 
x 
x 
Insulin-like growth factor 
x 
x 
x 
x 
Leptin 
x 
x 
x 
x 
Insulin 
x 
x 
x 
x 
Free T4 
x 
x 
x 
x 
Cortisol  
x 
 
 
x 
Ghrelin 
x 
x 
x 
x 
Urinary creatinine and urinary iodine 
x 
 
 
x 
Health outcomes 
Blood Pressure 
x 
x 
x 
x 
Serum Lipids  
x 
 
 
x 
Serum Vitamin D 
x 
 
 
x 
Fasting blood glucose 
x 
 
 
x 
Continuous glucose monitoring 
x 
 
 
x 
Compliance and Fitness Testing 

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8.2 Provide a description of: 
● 
All research procedures being performed  
● 
If the study has more than one procedure, session, and/or subject 
population, describe each procedure, session, and/or study 
population separately. For complex studies, you are encouraged to 
include a figure or chart. 
 
 
Phone Screen 
Those who respond to the investigation's advertisements will be scheduled to complete a 
brief telephone (or HIPAA-compliant Zoom) screening to confirm basic eligibility 
criteria.  Participants will be made fully aware of the eligibility criteria, time 
commitment, possible risks and their right to withdraw from the study at any time. A 
phone screening script and phone screening data collection form (uploaded) will be used 
for phone screening and will conclude with a brief oral diet history performed by a 
research team member who is also a registered dietitian nutritionist.  
 
Baseline Screening (approximately 45 minutes) 
Informed Consent: Participants will be provided an informed consent form following the 
phone screening and in advance of coming to the laboratory.    
 
Health History:  Subjects will be asked to complete a standard health/medical history 
questionnaire, which will be used to screen for health issues (e.g., coronary or congenital 
heart disease) or other reasons (medications which influence study results) that would 
preclude participation (see uploaded Health History Screening Questionnaire). This 
questionnaire has been used by Dr. Larson-Meyer for clinical studies for the past 17 
years. 
 
Physical Activity: Subjects will be asked to complete a questionnaire regarding habitual 
physical activity and exercise. 
 
Skinfolds: Skinfolds will be measured at specific anatomical sites that include the triceps, 
subscapular, biceps, iliac crest, supraspinale, abdominale, front thigh, and medial calf 
using Harpenden skinfold calipers according to ISAK procedures with the sum of 
skinfolds used as the outcome variable. Anthropometric breadths and girths will be 
Strength Testing  
x 
 
 
x 
Aerobic Capacity (VO2max) and walking efficiency 
x 
 
 
x 
Food Records and Appetite rating for 3-day 
x 
x 
x 
x 
Vitamin D Food Frequency and Lifestyle Questionnaire 
x 
 
 
 
Exercise tracking for 3-days (smart watch)  
x 
x 
x 
x 
Daily snack tracking logs and exercise logs 
← 
↔ 
↔ 
→ 
Questionnaire-Snack acceptability & exit survey 
 
 
 
x 

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obtained using a small sliding caliper and a flexible steel tape measure at the epicondylar 
humerus, epicondylar femur, midarm (relaxed and flexed), waist, hip, and calf. These will 
be used both as outcome variables and for initial somatotyping at baseline. This will be 
done by a trained investigator. 
 
Blood Draw: If the participant is able to come into the laboratory after a 12-hour 
overnight fast, blood will be drawn by venipuncture for the following: a CBC, TSH, 
testosterone (free and total), growth hormone, insulin-like growth factor, leptin, insulin, 
thyroid hormone, cortisol, ghrelin, blood glucose, and serum cholesterol. Blood will be 
collected during the baseline session if the participant is not fasted as outlined below. In 
total, blood will be draw four times during the study by venipuncture from a vein in the 
arm. These include baseline, and at 3, 7 and 11 weeks as explained below. Blood will be 
drawn with the participant seated quietly in a phlebotomy chair.  Approximately 20-25 ml 
will be obtained for screening/baseline.  
 
Baseline Laboratory Testing Session (approximately 2 hours and 30 minutes). 
All measurements will be performed in the morning after a 12-hour fast (no caffeine) 
with the participants instructed not to engage in heavy exercise for 36 hours prior to 
testing and to adequately hydrate the evening prior.  This visit may be split into two 
shorter visits.  
 
Resting Metabolic Rate (RMR; also called Resting Energy Expenditure):  Participants 
will lay supine on a bed. A clear ventilated hood will be placed over their head, neck and 
shoulders and plastic drapes will be tucked under them to avoid leakage of air.  Air will 
be pulled thru the hood with a pump and their expired air will be measured for oxygen 
and carbon dioxide content.  The number of calories expended will be calculated using 
the total volume of air expired and the oxygen and carbon dioxide content. The ratio of 
carbon dioxide produced to oxygen consumed will be used to estimate carbohydrate and 
fat utilization.  
 
Blood Pressure: Blood Pressure will be measured in the right arm using an automatic 
blood pressure monitor.  
 
Blood draws and hormone and metabolite analyses: If blood was not drawn at the 
screening visit, it will be drawn immediately after the RMR for a CBC and analysis of 
TSH, testosterone (free and total), growth hormone, insulin-like growth factor, leptin, 
insulin, thyroid hormone, cortisol, ghrelin, blood glucose and other factors. Blood will be 
drawn by venipuncture as explained above for screening. Approximately 20-25 ml will 
be obtained during the screening/baseline visit. 
  
Body Weight Height and Composition:  Body weight and height will be measured on a 
digital physician’s scale.  Percent body fat and fat-free mass will be measured in all 
subjects via DXA scan.  
 
Urine sample and pregnancy test:  All participants will be required to provide a small cup 
of urine immediately before the DXA. The urine will be evaluated for hydration status 

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via specific density using a refractometer. A pregnancy test will be performed on the 
urine sample for female participants.  
 
Walking Economy and Aerobic capacity (VO2max):  A graded exercise test will be 
performed on a treadmill to assess aerobic fitness via indirect calorimetry (Parvo Medics 
TrueOne 2400). Heart rate will be measured during the test by a heart rate strap and 
sensor. The exercise test will consist of walking or running on the treadmill starting at a 
self-selected pace with the grade or speed increasing every min until the participant 
reaches volitional exhaustion and can no longer continue.  The test will begin with a 
walking economy test in which the participant walks for 4-minutes at 2.5, 3 and 3.5 mph.  
The last two minutes of oxygen consumption and carbon dioxide production data will be 
used to determine metabolic economy (ml oxygen consumed per kg body weight per 
minute relative to the set work performed).  Following cumulation of the standard 
economy test, the workload will be increased each minute by increasing treadmill speed 
or grade by 0.5 mph or 2.5%, respectively  until the participants reach volitional 
exhaustion.  The entire exercise testing protocol (metabolic economy plus VO2max) will 
last 20-25 minutes. 
 
Dietary food records, exercise tracking, continuous glucose monitoring (CGM), and 24-
hour urine collection: Following laboratory testing, participants will be instructed on 
completing 3-day food records and exercise tracking, performing the CGM and 
completing the 24-hour urine collection. Participants will be asked to record all of the 
food they eat for 3 days, rate feelings of hunger and appetite using standardized appetite 
rating sheets, and wear a smart watch over this same time period. At baseline only, they 
will be asked to complete a food-frequency and lifestyle questionnaire specific to vitamin 
D intake/status simultaneously with the 3-day food records. The smart watch will use an 
app to measure heart rate and estimate energy expended during structured exercise or 
physical activity; this will be used to help estimate the participants total energy 
expenditure. It will be necessary to have the GPS function turned on during the collection 
of physical activity data but only data related to time, distance or intensity and not GPS 
coordinates will be downloaded or recorded. CGM will also coincide with the three-day 
food records using a device called a “Continuous Glucose Monitor” that is typically worn 
on the back of the upper arm.  This requires that a small amount of interstitial fluid (0.5 
microliters) be sampled every 15 minutes (96 times per day) throughout the course of the 
3-day measurement. In addition, participants will be asked to collect urine for 24 hours 
during one day of this recall or within the first week of the study.  Participants will void 
and discard the first morning urine sample and then collect all subsequent samples in 
provided clinical urine jugs for 24 hours, ending with the first sample upon waking the 
next day. Participants will schedule a time to drop off their urine during one of their 
resistant training sessions the first week or at a separate time, if it is more convenient. 
The instructions the participants will receive on using the Smart Watch, using CGM, and 
collecting the 24-hour urine are uploaded as an Addendum. 
 
Healthy Weight Gain Intervention 
 
Resistance Training: Participants will undergo rigorous resistance training three 
days per wk under close supervision. The following will be performed with weight 

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machines (Nautilus) and free weights: leg press, leg squat, leg extension, leg flexion, toe 
raise, lat-pull down, dead lift, shoulder press, bench press, bicep curl, triceps extension 
and abdominal twist/crunch. The overall goal will be to have participants perform 10 sets 
of exercises that work the major muscle groups each week in accordance with a recently 
published position stand of the International Universities Strength and Conditioning 
Association (IUSCA) (Schoenfeld et al 2021) with slightly different set of exercises 
performed on each of the three days. Participants will begin with light to moderate 
resistance for ~8-15 repetitions, after which resistance will be gradually increased over 
the following 5 workouts. After that, three to five sets of each exercise will be completed 
using modified methodology of Bartels et al in accordance with the latest guidelines for 
promoting muscle hypertrophy (Schoenfeld et al 2021).   The resistance training sessions 
will last approximately 60 to 75 minutes. 
 
         Dietary Intervention: The peanut group will be provided with a variety of whole and 
laboratory-prepared peanut-containing snacks to meet their daily excess energy. The 
snacks will be calculated to contain 500+/- 10 kcal and 15 grams of protein (using 
Nutrition Data System for Research nutrient analysis software).  A complete list of these 
snacks is uploaded as supplemental files. The control group will be provided similar 500 
kcal high carbohydrate containing snacks that contain ~5 g protein.. Participants will be 
informed that they are in the peanut or non-peanut group but the dietary composition 
differences between these snacks will not be mentioned or discussed. Participants will be 
encouraged to consume snacks within an hour of resistance training and/or before bed 
(Phillips and Van Loon 2011). Participants in both groups will be allowed to select from 
several different snack options offered each week. Participants will also undergo weekly 
assessments during one of the resistance training sessions to ensure compliance and 
adequate progress with excess energy adjusted upward with weight gain to avoid the 
potential effects of acute energy imbalance due to total body/lean mass gain and help 
ensure adequate (~0.5 pounds/week) but not excessive (>1.5 #/week) weight gain.  
 
         Daily Snack and Exercise Tracking Logs: Participants will keep daily record of 
consumption of the provided snacks as well as other exercise training undertaken using a 
simple snack and exercise tracking log.  These logs require participants to place a check 
mark by snacks consumed and to quickly fill in time spent in other exercise training 
activities. Logs will be turned in to the researchers every two weeks during resistance 
training sessions.  
 
       Strength and Fitness Testing: Strength of a major upper and lower body group (i.e. 
bench press and leg press) will be assessed on the Nautilus equipment at the beginning 
and end (wk 11) of the 10-wk program by recording the maximal weight that can be lifted 
once correctly.  The change in the aforementioned 80% RM value will also be 
documented for use as data points.  
 
Week 3 Laboratory Testing Session (approximately 75 minutes) 
This session will be scheduled at the end of week 3/beginning of week 4 and will be 
performed in the morning after a 12-hour fast (no caffeine) with the participants 
instructed not to engage in heavy exercise for 36 hours prior to testing and to adequately 

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hydrate the evening prior.  As outlined in the Table, all tests conducted as part of baseline 
testing will be performed except for CGM, 24-hour urine collection, walking economy 
and aerobic capacity. Blood will be drawn by venipuncture from a vein in the arm with 
the participant seated quietly in a phlebotomy chair. Blood and urine will be analyzed for 
selected hormones and metabolites (as outlined in the Table). Approximately 15 ml will 
be obtained for the Week 3 visit. 
 
Week 7 Laboratory Testing Session (approximately 60 minutes)   
This session will be scheduled during week 7 and will be performed in the morning after 
a 12-hour fast (no caffeine) with the participants instructed not to engage in heavy 
exercise for 36 hours prior to testing and to adequately hydrate the evening prior.  As 
outlined in the Table, all tests conducted as part of baseline testing will be performed 
except for the RMR, CGM, 24-hour urine collection, walking economy and aerobic 
capacity. Blood will be collected but analyzed only for selected hormones and 
metabolites. Blood will be drawn by venipuncture from a vein in the arm with the 
participant seated quietly in a phlebotomy chair.  Blood will be analyzed for selected 
hormones and metabolites (as outlined in the Table). Approximately 15 ml will be 
obtained for The Week 7 visit. 
 
Week 11 Final Testing Session (approximately 2 1/2 hours) 
This session will be performed as outlined in the Baseline testing section. Blood will be 
drawn by venipuncture from a vein in the arm with the participant seated quietly in a 
phlebotomy chair.  Blood will be analyzed for all hormones and metabolites analyzed at 
baseline except the CBC.  Approximately 20 ml will be obtained for screening/baseline. 
Participants will also provide feedback related to the palatability and ease of consumption 
of the snacks they consumed on a questionnaire and also be asked to complete a brief exit 
survey. 
 
 
 
 
8.3 Describe: 
● 
Procedures or safeguards intended to reduce the probability and 
magnitude of risks. (For example: Reducing the risk of injury in a 
virtual reality study either by having the subjects sit during the study 
or by providing an obstacle-free space for walking.) 
● 
Be sure to describe all drugs and devices used in the research, when 
they will be administered or used, and their purpose.  
● 
Methods used to collect data about subjects. Please upload all data 
collection forms to Protocol Management. Some common examples 
are: 
● Screening questionnaires  
● Survey(s), including online surveys 
● Demographic questionnaire(s) 

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● Interview guide(s), e.g., questions or pool of questions for semi-
structured interviews  
● Focus group guide(s) 
● Other documents used to collect data  
 
The following safeguards will be employed to reduce the probability and magnitude of 
risks associated with study participation. The specific risks are highlighted in Section 17.  
 
Resistance training: Potential risks associated with resistance training include severe 
muscle soreness, muscle or joint strain or injury or an abrupt elevation of blood pressure. 
These risks will be minimized by enrolling young healthy participants who have had 
prior experience with resistance training and, supervising all training sessions (with 
emphasis on proper form, lifting procedures) and tapering resistance over the first ~2 
weeks.  
 
CGM: Potential risks associated with the CGM include discomfort during the insertion, 
pain, inflammation, redness/rash, swelling, minor bleeding and minor infection at the site.  
These risks will be minimized by having a trained member of the research staff perform 
the procedure under aseptic conditions. Participants might also experience the 
aforementioned symptoms as a result of contact between the adhesive pad of the sensor 
and the skin. In rare cases, an infection can spread to other parts of the body. Allergic 
reactions can develop in response the adhesive used to keep the CGM in place. If these 
symptoms occur, participants have the ability to remove the CGM at will.  Symptoms 
typically resolve within a short time (approximately one week). 
 
Questionnaires and Study Logs: All study questionnaires (except the food records, 
exercise logs and snack logs) will be collected with the participant sitting in a private 
setting in the laboratory. Questionnaires will be placed in each participant’s study file 
date entered for data analysis. 
 
Blood draws: Blood will be collected using universal precautions by a trained technician. 
Blood will be drawn by venipuncture from a vein in the arm with the participant resting 
in a phlebotomy chair.  Blood will be drawn at four times during the study 
(screening/baseline, 3 weeks, 7 weeks and 11 weeks) with a total of 75 ml of blood 
collected over the course of the 12-13 weeks. 
 
DXA scan: DXA procedure will be performed by trained staff. Participants will be 
informed of the risk of radiation exposure prior to study enrollment. Female participants 
will complete a pregnancy test by urine immediately before the DXA. 
 
VO2max/Aerobic capacity: Trained research personnel will be present during the test to 
correctly place the mouthpiece, monitor all variables during the test and support the 
participant at the end of the test.  
 

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8.4 What data will you collect during the study and how you will obtain them? 
Please include descriptions of electronic data collection, database 
matching, and app-based data collection: 
 
Anthropometric, basic demographic (sex, age), RMR, and exercise testing data will be 
recorded on data sheets and manually entered into a database (excel format) on a secure 
computer as outlined in section 8.2 above. Select data (DXA results, RMR, VO2max) 
may be transferred electronically directly from the DXA or metabolic cart into excel 
spread sheets if possible. Blood and urine results will be entered directly from laboratory 
sheets provided by a commercial laboratory or the Metabolic Core at Virginia Tech. 
Heart rate, energy expended and exercises performed will be downloaded onto the 
laboratory computer from the Smart Watch. Glucose concentration in interstitial fluid 
samples by time will be downloaded directly from the CGM sensor onto the lab 
computer.  The majority of lab collection sheets are uploaded with this application. 
 
8.5 Who will transcribe or code audio and/or video recordings?: 
 
N/A 
 
8.6 Include a description of any deception to be used in the study. Include 
justification for the use of deception (why the deception is necessary), 
describe the debriefing process, and describe how the study meets all the 
following criteria  for alteration of consent (deception is considered an 
alteration of informed consent): 
• The research involves no more than minimal risk to the subjects 
• The alteration will not adversely affect the rights and welfare of the 
subjects 
• The research could not practicably be carried out without the 
alteration/deception 
• (Optional but encouraged in most cases) Subjects will be provided with 
additional pertinent information after participation (i.e., debriefing for 
studies involving deception)  
 
 
N/A 
 
 
8.7 If the study involves long-term follow-up (once all research related 
procedures are complete), describe what data will be collected during the 
follow up period and when it will occur:  
 

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N/A 
 
9.0 
Data and Specimen Long Term Storage and Use 
9.1 If you will store data or specimens for future use, describe where you will 
store the data or specimens, how long they will be stored, and how and by 
whom the data or specimens will be accessed: 
 
All data will be stored in a locked cabinet in Dr. Larson-Meyer's laboratory which will 
also be locked to only authorized personnel. The computer data will be stored in the 
locked lab on a computer that is password protected. All de-identified data will be kept 
indefinitely.  
 
9.2 For specimens, list the data to be stored or associated with each 
specimen: 
Blood and urine samples will be stored in a -80-degree freezer in the HIP 
laboratory currently located in the Garvin Building. Samples will be 
labeled with the participants’ study code (see section 9.4 below), the visit 
number and the date and time of the collection. No identifying information 
will be written on specimen samples. The freezer is located in locked 
room/laboratory. 
 Blood analyzed by the Metabolic Core at Virginia Tech, housed in the 
Integrated Life Sciences Building, may also be temporarily stored in a 
freezer in this laboratory immediately before, during or after analysis.   
 
9.3 Describe the procedures to release data or specimens outside of the 
research team, including the process to request a release, approvals 
required for release, who can obtain data or specimens, and what data 
will be provided with specimens: 
 
Some de-identified blood and urine samples will be sent to a commercial 
laboratory for analysis.  There are currently no plans to release data 
outside of the research team.  
 
9.4 Describe the identifiers to be included with stored data or specimens, as 
well as any key or code that could be used to make them identifiable. 
Describe where the code will be stored, who will have access to it, and 
when it will be destroyed: 
 

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Study Codes using a combination of letters and numbers will be used to de-identify 
subjects from their personal information. No obvious identifiers will be stored with the 
data; the data spreadsheet, however will include each participants age, sex and starting 
weight as part of the de-identified data.  Original de-identified data collection sheets will 
be stored in a locked file cabinet as part of study records; scans of some de-identified 
information may be kept in a password-protected electronic file that is accessible only to 
research personnel. During the active phase of the study, a master document (key) that 
will contain the participants name, assigned study code and randomization order will be 
kept in a password-secured file that will be accessible only to the PI, co-investigator, 
study coordinator (EM) and doctoral student in charge of the study (Allison Sanchez). 
The key will be destroyed 6 to 12 months after collection of data from the last participant. 
De-identified data may be kept indefinitely. Blood and urine samples will be destroyed 
after 5 years. 
 
9.5 Please select the identifiers you will obtain (whether directly from 
participants or from another source), including but not limited to: 
 
☒ 
Name 
☒ 
Geographical subdivisions smaller than a state, including street address, 
city, county, precinct, zip code, and equivalent geocodes (note, the initial 
three digits of a zip code are not considered identifiable) 
☒ 
Elements of dates (except year) for dates directly related to an individual, 
including birth date, admission date, discharge date, date of death, and 
single year of age over 89 and all elements of dates (including year) 
indicative of such age (note, such ages and elements may be aggregated 
into a single category of age 90+) 
☒ 
Phone numbers 
☐ 
Fax numbers 
☒ 
Electronic mail addresses (e-mail) 
☐ 
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 (audio recording) 
☐ 
Full face photographic images and any comparable images (including 
video recording) 
☐ 
Student record number or identification number   

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☐ 
User name for online or computer accounts 
☐ 
Any other unique identifying number, characteristic, or code (note this 
does not mean the unique code assigned by the investigator to code the 
data): Click here to explain.   
 
10.0 Sharing of Results with Subjects 
10.1 Describe whether you will share results (study results or individual subject 
results, such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) with subjects or others (e.g., the subject’s primary care 
physician). If so, describe how you will share the results and include this 
information as part of the consent document. Upload materials you will use 
to explain the results to subjects: 
 
At the conclusion of the study or when the participants' involvement in the study ends, 
interested participants will be provided with individual results related to their body 
composition, fitness, resting energy expenditure and pertinent blood markers (blood 
sugar, serum cholesterol, TSH, etc). These data will be summarized on a TBD summary 
document that the participant can pick up at the lab or have (upon request) mailed to them 
at a provided address. This form will be submitted as an Addendum before it is provided 
to the first participant. Participants will only be provided results during the study if it is 
determined that the participant has a result for any measured outcomes that is out of the 
normal range; in this case the participant would be provided information about the value 
and asked to see their personal health care provider. The participants will also be notified 
when a summary of the study findings is published if an active email address is on file.   
 
11.0 Study Timelines 
11.1 Describe: 
● 
The duration of an individual subject’s participation in the study (for 
example, 1 hour, 2-4 weeks, 3-5 years). 
● 
The amount of time expected to enroll all study subjects (weeks, 
months, years, etc.) 
● 
The amount of time expected for the investigators to complete this 
study including primary data analyses. 
The duration of an individual's participation in this study will be approximately 12 to 13 
weeks, which will include a Zoom or telephone call for screening, a short screening visit 
in the laboratory, a baseline visit, follow up visits at 3, 7 and 11 weeks, and 10 weeks of 
supervised resistance training, three times per week. The actual time and frequency of the 
subject's visits will depend on their schedule and that of the study staff. Participants will 
begin the study on a rolling basis, but the entire study will take place across 
approximately one year as dictated by the funding agency.  The investigators will 
complete primary data analyses within the following year but all analyses of study data 
may not occur for up to ten years following study completion.  
 

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12.0 Inclusion and Exclusion Criteria 
12.1 Describe how you will screen individuals for eligibility. When will 
screening occur and what procedures will you use? Upload any screening 
scripts or surveys to Protocol Management:  
Those who respond to the investigation's advertisements will be asked to complete a brief 
telephone (or Zoom) screening to confirm basic eligibility criteria.  Participants will be 
made fully aware of the eligibility criteria, time commitment, possible risks and their 
right to withdraw from the study at any time. A phone screening form (uploaded) will be 
used for this purpose and will conclude with a brief oral diet history performed by a 
research team member who is also a registered dietitian nutritionist (RDN).  
 
12.2 Describe the eligibility criteria that define who will be included and who 
will be excluded from enrollment for each procedure of your study. 
Include any geographic criteria (e.g., Virginia Tech undergraduate 
students, a national sample of adults with engineering degrees, minors 
aged 8-12 in the New River Valley, university faculty in Virginia and 
Paris, France): 
 
To be eligible, participants must be in good overall health with the desire to gain at least 
5 pounds of body weight to enhance effectiveness in sport, fitness, or military 
training/competition. Participants of all body sizes will be allowed to participate as long 
as they meet the aforementioned criteria (desiring weight gain for sport, fitness or 
military/training/competition); this will very likely involve enrolling some athletic 
women or military women who weigh less than 110 pounds at study start. Participants 
will not be considered if they smoke, are pregnant, have coronary heart disease, have 
hypertension (on blood pressure medications), have  medical and/or orthopedic 
limitations that might affect the ability to fully participate in the study, are currently 
taking any dietary supplements or prescribed pharmacological agents that might affect 
lean tissue accretion, have a current or past history of anabolic steroid use, have a history 
of or current signs of disordered eating (score >20 on the Eating Attitudes Test), or have 
an allergy to peanuts and/or tree nuts. Participants will also be excluded if they have an 
abnormal TSH or hemoglobin (obtained at screening), have high blood pressure (>140/90 
mmHg), abnormal serum lipids (e.g. fasting triglycerides <150 mg/dL and total 
cholesterol <200 mg/dL),  have not previously participated in strength/resistance training 
as part of athletic or military training within the last year or are currently not involved in 
sport, or military or strength/resistance training at the recreational, high school, collegiate 
or elite level. Prior to enrollment, detailed diet and exercise data will be collected via a 
diet history to ensure participants are consuming adequate energy (relative to estimated 
energy expenditure) and sufficient protein (>1.2 g/kg) from a balanced diet at baseline. 
The Eating Attitudes Test will be used to screen for disordered eating patterns and help 
ensure that participant desire to gain weight is not due to general undereating, unhealthy 
eating patterns or disordered eating. Individuals who score >20 will be encouraged to 
follow up with their health care provider and provided a list of Registered Dietitians in 
the Area who specialize in the treatment of disordered eating.  

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12.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of these 
populations as subjects in your research unless you indicate them in the 
description of your subject population.) 
● 
Minors, as defined by state law where the study is performed 
(infants, children, teenagers) 
● 
Pregnant women (can be included in minimal risk studies by 
mentioning in section 13.1) 
● 
Prisoners (including all incarcerated individuals) 
● 
Adults not capable to consent on their own behalf 
 
None of the above will participate. 
Pregnant women are excluded both because their inclusion would interfere with our study 
results (i.e., weight gain during pregnancy is different than what we are studying) and 
because vigorous strength/resistance training with the intent of lean body gains for 
enhanced sport or military performance is not appropriate during pregnancy.   
 
13.0 Vulnerable Populations 
13.1 If the research involves individuals who are vulnerable to coercion or 
undue influence, please describe additional safeguards you will include to 
protect their rights and welfare. Consider the applicable items listed 
below: 
● 
If the research involves Virginia Tech students, indicate whether 
these are students of any of the investigators. If so, describe whether 
the activities will take place during class time as part of the 
curriculum and the steps you will take to reduce the possibility that 
students feel obliged to participate in order to improve their course 
grade. The HRPP can provide further guidance as needed. Describe 
whether you will request access to student records (e.g., SAT, GPA, 
GRE scores). 
● 
If the research involves employees of Virginia Tech or the research 
sponsor, describe steps you will take to ensure that the employees 
are freely participating and describe how their data will be 
protected from inspection by their supervisors.  
● 
If the research involves Virginia Tech NCAA athletes, you must 
obtain approval from the athletic department.  
● 
For research involving Montgomery County Public Schools, you 
must obtain county approval (after obtaining contingent Virginia 
Tech approval). Other locales have different requirements; please 
check on these and describe here. Approval is typically granted by 
the superintendent, principal, and classroom teacher (in that order). 
Approval by an individual teacher is insufficient. School approval, in 

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the form of a letter or a memorandum should be uploaded as a 
supporting document. 
● 
If the research involves pregnant women, review “CHECKLIST: 
Pregnant Women (HRP-412)” to ensure that you have provided 
sufficient information in this protocol. 
● 
If the research involves prisoners, review “CHECKLIST: Prisoners 
(HRP-415)” to ensure that you have provided sufficient information 
in this protocol. 
● 
If the research involves persons who have not attained the legal age 
for consent to treatments or procedures involved in the research 
(minors), review the “CHECKLIST: Minors (HRP-416)” to ensure 
that you have provided sufficient information in this protocol. 
● 
If the research involves cognitively impaired adults, review 
“CHECKLIST: Cognitively Impaired Adults (HRP-417)” to ensure 
that you have provided sufficient information in this protocol. 
 
This research study has the potential to include students and employees of Virginia Tech. 
However, during the consenting process, the participants will be made aware that only 
members of the research study team will have access to their data and that this data will 
utilize a coding system making their data unidentifiable. This data will be locked away 
and they will be made fully aware of their right to withdraw from the study at any time.  
If Virginia Tech athletes are interested in the study, they will only be allowed to 
participate during their off-season and after first obtaining approval from the athletics 
department. 
 
 
 
14.0 Number of Subjects 
14.1 Indicate the total number of subjects to be enrolled and how this number 
was determined (e.g., sample size calculation [show], number of available 
subjects in a finite pool, number of tests funding award would allow):  
 
The sample target of 16 men and 16 women was selected because we 
believed it would be feasible to recruit and study this number within the 
time frame and budget set by the funding agency.  We, however, will 
target recruitment of up to 40 participants. Based on limited previous 
studies in men who have used a range of 12 to 46 subjects, we also believe 
this number is sufficient to show measurable results.  
 
14.2 If this is a multi-site study, indicate the number of subjects to be enrolled 
at this site and the total to be enrolled from all sites: 
 
N/A 

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14.3 If applicable, indicate the number of potential subjects you expect to 
screen for enrollment, and the number of subjects you will need to 
complete the research procedures: 
 
We anticipate that we may need to screen between 100 and 150 
participants to recruit and complete the required 32 participants. 
 
14.4 If the study has more than one procedure, indicate the total number of 
subjects to undergo each procedure separately: 
 
20 participants (~10 men/10 women) will be assigned to the peanut-
containing snack group and 20 participants (~10 men/10 women) will be 
assigned to the control snack group as previously mentioned.  
 
15.0 Recruitment Methods 
15.1 Describe when, where, and how you will recruit potential subjects: 
 
Participants will be recruited through flyers placed at strategic locations 
(gyms, fitness, military and recreational centers, etc.), at colleges and 
universities in the New River Valley (including Virginia Tech) and 
through targeted listservs (VT News), emails, and social media posts.  
 
15.2 Describe the source of subjects (for example, clinic patients with specific 
conditions, students in the library, community members at a gathering, or 
members of a local gym): 
 
We will recruit from the general population of athletes and active 
individuals and those involved with and enlisted in the military. This will 
include recruiting members of local gyms and fitness centers. 
 
15.3 Describe the methods that you will use to identify potential subjects: 
 
As mentioned previously above (15.2), we will identify participants 
through use of flyers placed at strategic locations and through targeted 
listservs, emails and social media posts.   
 

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15.4 Describe materials that you will be use to recruit subjects. Attach copies 
of these documents with this protocol in Protocol Management and be 
sure to include the IRB protocol number on each document.  
● For flyers, attach the final copy of printed flyers.  
● For Virginia Tech News, Facebook postings and ads, newspaper ads, 
websites, MTurk/SONA/online survey systems, etc., attach the final 
wording and graphics to be used.  
● For email recruitments, please include the subject line.  
● For advertisements meant for audio broadcast, please submit the 
wording of the advertisement prior to taping (to avoid having to re-
record with approved language) and submit the final recorded version 
for IRB review before use.  
● Describe any compensation to subjects. Separate compensation into 
appropriate categories, such as: reimbursement for expenses, time and 
effort, and additional incentives for study participation.  For each 
category, specify the amount (including any pro-rated amount), schedule, 
and method of payment. 
 
A draft copy of our recruitment flyer is uploaded.  This flyer will be posted at 
strategic locations throughout Blacksburg and the surrounding area. We will seek 
permission at each site as necessary before posting or hanging a flyer. We also 
plan to use this same advertisement for emails and a modified version for social 
media posts (that will be submitted for approval at a later date as an Addendum).  
Emails will use the subject line "Are you interested in participating in a research 
study on weight gain to enhance effectiveness in sport, fitness or military 
training?". Participants will be compensated $10 for completing the baseline visit 
(not screening visit), $20 for completing the 3-week visit, and $20 for 
completing the 7-week visit. Participants will be compensated an additional $150 
at study end for completing a minimum of 85% of the 10-week training sessions 
and the final (11-week) visit. This is a total of $200 compensation for completion 
of all testing visits and at least 85% of the training sessions. Payments will be 
scheduled after each individual participant completes each of the above visits. 
Active duty can only accept compensation for blood draws (up to $50 per draw). 
 
 
16.0 Withdrawal of Subjects 
16.1 Describe circumstances under which you anticipate subjects could be 
withdrawn from the research without their consent: 
 
Participants could be withdrawn from the study if they are not showing up 
for appointments and/or training sessions, are not consuming the provided 
snacks, or are not completing or complying with all procedures. They also 
may be withdrawn if they develop and injury or illness that would prevent 

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them from doing everything that is expected for the study or which might 
compromise their health.  
 
16.2 If applicable, describe any procedures for orderly termination (e.g., 
discontinuation of a study drug or debriefing after a behavioral 
intervention): 
 
If a participant is not complying with the study, the PI or study coordinator will first 
discuss these difficulties with the participant and explain the importance of adhering to 
the intervention for the purpose of the study. If it is determined that the participant be 
terminated or discontinued from the study for reasons as described above, the PI will 
mitigate issues leading to these problems. The participant will be provided any 
information which is available to them (baseline body composition, fitness testing, 
resting metabolic rate). It will then be suggested that the study personnel part ways with 
the participant 
 
16.3 Describe procedures that you will follow when subjects withdraw from the 
research, including partial withdrawal from procedures with continued 
data collection (e.g., participant declines to continue with regular blood 
draws, but continues with periodic behavioral questionnaires): 
Any participant can discontinue participation at any point without consequence. 
 
17.0 Risks to Subjects 
17.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in the 
research. Include for the IRB’s consideration a description of the 
probability, magnitude, duration, and reversibility of the risks. Consider 
physical, psychological, social, legal, privacy, and economic risks. Do not 
indicate “No risk” or “N/A.” Instead, for studies with very low risk (e.g., 
anonymous online questionnaire on a mundane topic) indicate “The 
investigators are not aware of any risks from participation in this study.” 
or “No more than risks than are found in everyday life.” The example 
consent form presents a tabular method for risk information, which you 
can also use here. Common risk types include: 
● Physical (e.g., potential for pain, discomfort, infection) 
● Psychological (e.g., potential for stress, discomfort, and/or 
embarrassment) 
● Social (e.g., potential for discrimination or stigmatization and 
disruption of personal and family relationships) 
● Legal (e.g., potential for disclosure of illegal activity, negligence) 

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● Privacy (e.g., potential for personal information being accessed, used, 
or disclosed without the subjects’ knowledge or consent, breach of 
confidentiality/security) 
● Economic (e.g., potential for individuals to lose access to economic 
services, employment, insurability) 
 
Resting Metabolic Rate: Risk of claustrophobia or feelings of anxiety during testing when 
the clear ventilated hood is placed over their head. To minimize this risk, participants will 
be screened for claustrophobia and monitored for signs and symptoms that can include 
sweating, shakiness, tachycardia, increased or rapid breathing, nausea, light-headedness, 
fainting and fear of actual imminent physical harm.  An investigator will monitor this test 
to ensure participant safety.   
 
DXA Scan: The amount of radiation that subjects will receive in the DXA exam is less 
than the amount permitted by the Food and Drug Administration (FDA) per year. The 
amount subjects will receive at each scan is equal to 1/20 of a chest x-ray. The more 
radiation an individual receives over the course of their lifetime, the more likely that 
individual’s risk increases in developing cancerous tumors. The radiation in this study is 
not expected to greatly increase these risks, however, the exact increase in such risk is not 
known. 
 
Blood draws: Slight discomfort may be expected during blood draws. Risk of developing 
a small bruise or blood clot in the vein, risk of fainting or dizziness, risk of infection and 
risk of bleeding are also possible. Universal Precautions will be followed for collection, 
handling, processing, and disposal of items that may have come into contact with bodily 
fluids during the collection of blood. Blood draws will be performed by a research 
phlebotomist (J Rinehart) trained and experienced in the blood draw procedure and in 
handling minor emergencies such as dizziness and fainting. In case of an emergency, 911 
will be called. 
 
Walking Economy and Exercise Capacity (VO2max):  There is a small risk of orthopedic 
injury, treadmill falls or cardiovascular complications that could require a participant to 
go to the hospital. This includes a heart attack, or even death.  In studies involving people 
with heart disease, the risk of hospitalization was 1 in 500 tests <0.20%).  The risk of 
heart attack was 1 in 2,500 tests (0.04%) and death, 1 in 10,000 tests (0.01%).  The risks 
are likely to be lower in young, healthy subjects who are involved in athletic training 
and/or exercise.  Only experienced staff members will conduct these tests and subjects 
will be monitored throughout the test for signs of problems based on standards of the 
American College of Sports Medicine (ACSM).  There is a possibility some subjects will 
be tired after this test and could have sore muscles for a few days. 
 
24-hour urine collection: There are no risks for urine collections. However, 24-hour urine 
collections may present some inconvenience and/or embarrassment. The inconvenience 
will be minimized by the provision of a reusable shopping bag to make carrying and 
storage discrete. Also, female participants will be provided with a female urination devise 
to make this collection easier. 

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Continuous Glucose Monitoring. The placement of the device will require that a sensor is  
inserted into the back of the participant’s upper arm. Placement of the sensor may  
induce some pain during the insertion, inflammation, redness, swelling, 
minor bleeding and/or minor infection at the site. This will all be minimized by having a 
trained individual perform the procedure which will take place in aseptic conditions. 
There is also a possibility a participant may experience these symptoms as a result of 
contact between the adhesive pad of the sensor and the skin; allergic reactions can also 
develop in response to the adhesive used to keep the device in place. 
If any of these symptoms occur, the participant will be informed that he/she has the 
ability to remove the CGM and these issues will clear up within a short time period. 
 
Dietary Intervention: There are no real risk to consuming the intervention snacks. The 
peanut group will be provided with a variety of whole and laboratory-prepared peanut-
containing snacks to meet their daily excess energy target of ~500 kcal whereas the 
control group will be provided a variety of high-carbohydrate snacks. There is a very 
small chance a participant might develop an allergy or intolerance to one of the snacks.  
To help avoid this issue, we will screen for a history of food allergies and intolerances 
including allergies to legumes, peanuts and tree nuts, as well as eggs, dairy, gluten and 
fermentable carbohydrates. 
 
Resistance (Weight) Training: This project will use standard resistance training 
procedures with Nautilus equipment that follows ACSM and IUSCA guidelines. Major 
health organizations recommend resistance training for all age groups, and have found it 
to be safe with low risk of injury. The most likely possible risk includes muscle soreness. 
Other possible risks include muscle or joint injury or an abrupt elevation of blood 
pressure. Our program will recruit only participants who have previous experience with 
resistance training. The resistance training sessions will be supervised by ACSM-certified 
personal trainers and emphasize proper form, lifting procedures, and breathing 
techniques. The program will also be tapered upward over the first ~2 weeks to help 
prevent excessive muscle soreness and muscle or joint strain.  Increases in blood pressure 
are also unlikely in the population studied. The participants will be informed to contact 
the PI or any member of the research team in the case of any injury or excessive joint or 
muscle strain.   
 
17.2  Indicate the measures you will use to minimize risks and monitor subjects 
for safety. (e.g., asking a subject at regular intervals to rate how they are 
feeling from 1 to 10, or to slowly crouch in order to check their balance.) 
Indicate the measures you will use to minimize risks and monitor subjects 
for safety. (e.g., asking a subject at regular intervals to rate how they are 
feeling from 1 to 10, or to slowly crouch in order to check their balance.) 
 
Included in Section 17.1 
 

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17.3 If applicable, indicate which procedures might have risks to the subjects 
that are currently unforeseeable. This will be rare, and usually applicable 
when testing a new drug or device or a new use of an existing drug or 
device: 
 
It is possible that participants could develop severe muscle soreness by 
participating in our rigorous resistance training regimen.  It is also possible 
an unknown allergy to peanuts could be identified during the study.  These 
events, however, are not likely.  To minimize the potential, we will slowly 
increase the resistance (weight) used during training over the first 2 weeks 
and are also recruiting participants who have some previous history of 
strength/resistance training.  A previously known allergy to legumes, nuts 
or tree nuts is an exclusion criterion for the study.  
 
17.4 If applicable, indicate which procedures might have risks to an embryo or 
fetus should the subject be or become pregnant: 
 
There is minimal risk if a female participant were to become pregnant during the 10 
weeks of the study.  The most recent committee opinion of the American College of 
Obstetricians and Gynecologists (April 2020) states that physical activity and exercise 
(including resistance exercise) in pregnancy are associated with minimal risks and have 
been shown to benefit most women.  Pregnancy tests will be performed at four timepoints 
during the study (specifically before each DXA), to ensure the participant is not pregnant.  
Participation in the study would end if it were determined the participant had become 
pregnant.  
 
 
17.5 If applicable, describe risks to others who are not subjects (e.g., collection 
of sensitive health data that might affect sexual partners if disclosed, 
mandatory reporting of abuse, DNA testing that might affect family 
members or relationships): 
 
N/A 
 
18.0 Potential Benefits to Subjects 
18.1 Describe the potential benefits that individual subjects might experience 
from participating in the research. Include the probability, magnitude, and 
duration of the potential benefits, as this will be useful to the IRB’s 
risk:benefit analysis. Do not include benefits to society or others. Do not 

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list monetary or non-monetary compensation for participation, as this is 
not a benefit These should be included in section 2 or 3 of this document: 
 
Participants will gain information about their body composition, resting 
metabolism, fitness, and general health.  They will also learn about healthy 
weight gain regimens and how to properly perform strength/resistance 
training exercises.  
 
18.2 If applicable, specify that there are no anticipated direct benefits for 
participants:  
 
N/A 
 
 
19.0 Data Management and Confidentiality 
19.1 Describe procedures that you will use for quality control to ensure validity 
of collected data: 
 
Drs. Larson-Meyer and Davy have extensive experience performing data 
collection on all of the procedures outlined in this proposal as does the 
study coordinator, Dr. Elaina Marinik. They will ensure all study 
personnel, including graduate students, will be properly trained to perform 
all procedures according to standard protocol. Specific quality control 
measures will be employed to ensure valid indirect calorimetry data are 
collected during the RMR, walking economy and VO2max tests; These 
standards are included on data collection sheets for use by members of the 
study team.  
 
19.2 Describe any existing data or biospecimens you will obtain as part of this 
study. Include:  
● 
Variables or samples to be obtained  
● 
Source of the data or specimens 
● 
Your authorization to access or receive the data or biospecimens 
● 
Whether the data or biospecimens are publicly available 
● 
Whether the data or specimens you receive will contain identifiers  
 
N/A 

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19.3 Describe the steps that you will take to handle and secure study data 
during data collection, storage, use, and transmission.  Include 
information about training of study staff, authorization of access, 
password protection, encryption, physical controls, certificates of 
confidentiality, separation of identifiers and data, etc.: 
 
We will do everything that we can to make sure that study records are kept private. Each 
participant will be assigned a unique participant code as explained in section 9.4.  All 
data recording sheets and spread sheets will use the subjects’ study code. They will not 
contain the participants’ name or date of birth. These will be compiled in a patient 
research file/chart and stored in a locked file cabinet organized by their unique study 
code. Their name will be listed only on the phone screening log (which is to be blackened 
out after they are assigned a participant code), informed consent and on a master 
participant list that includes the randomization key.  The master participant list will be 
kept in a separate electronic file than the data files; both will be password-protected. The 
study consents will be kept together in a separate file in a separate location in a locked 
office. Only authorized study personnel will have access to study data.  Results of the 
study may be published and/or presented at professional conferences. The participants’ 
name or other personal information that would identify them will not be used. All blood 
collected and post-processed serum and plasma samples will be labeled with the 
participants unique study code (plus the study visit and date and time of sample 
collection) and stored in a secure freezer in a locked laboratory until analysis as 
mentioned in section 9.2. Archives may be kept for up to five years following study 
analysis. Training of study personnel including graduate students on procedures to ensure 
secure collection and storage of study data will occur before study initiation.  
 
19.4 For multi-site studies, describe how data or specimens will be handled 
and secured for each site (e.g., central or disseminated data storage, data 
coordinating center): 
 
N/A 
 
19.5 Describe the plan for data disposition following the conclusion of the 
study (e.g., long term maintenance of data, data destruction methods).  
● 
What information will be included in the long term storage of data 
or specimens? 
● 
How long will the data or specimens be stored? 
● 
Where and how data or specimens will be stored? 
● 
Who will have access to the data or specimens during long term 
storage? 

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● 
Who is responsible for receipt or transmission of the data or 
specimens? 
● 
How will data or specimens be shared or transported? 
● 
When and how will personal identifiers be destroyed? 
 
 
Telephone screening forms (that contain participants’ names) and the Eating 
Attitudes Tests will be shredded immediately after all study participants are 
recruited.Personal information, primary and secondary endpoints and safety 
data will be kept indefinitely in a secured electronic location by the PI and co-
investigator. Personal information will be kept in a separate file than de-
identified data. Blood and urine samples labeled with the patients' unique study 
code may be stored in a laboratory freezer in a locked laboratory for up to five 
years following the completion of the analyses; only authorized study personnel 
will have access to freezer samples. The PI will be responsible for transmission 
of all data or achieved specimens.  Although is not anticipated that any data will 
need to be transported or shared, this would be done only using de-identified 
data with samples sent using a secure mechanism.   
 
 
20.0 Provisions to Protect the Privacy Interests of Subjects 
20.1 Describe the steps that you will take to protect subjects’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on with whom 
they interact or to whom they provide personal information (e.g., 
collecting the minimal amount of private information required to complete 
the study, protecting the data once it is obtained):  
 
To ensure privacy interests of all interested and enrolled participants, only 
the minimal amount of personal information and health history will be 
obtained using a standard health history form; this form has been used by 
Dr. Larson-Meyer for the past 17 years)  This data will be kept in 
participant files labeled with only the participants’ study code in a secured 
file in a locked room.  The data for all participants who do not participate 
in the study will be destroyed by shredding.  The data for participants who 
do enroll will be entered into an electronic data base using the participants 
assigned unique study code. Any and all original data collection sheets 
with the participants’ name or identifying information will also be 
destroyed following entry into the database.   
 
20.2 Describe steps that you will take to make subjects feel at ease with the 
research situation in terms of the questions being asked and the 
procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in 
response to questions, examinations, and procedures (e.g., use of a same 

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gender investigator to place sensors on the torso, a private changing area 
if clothing must be changed, sensitivity when discussing  pregnancy testing 
with subjects, making it clear on surveys that participants can discontinue 
at any time, not asking questions about private or sensitive issues unless 
necessary for the research): 
 
All questionnaires and anthropometric testing will be performed by trained 
research personnel in a private setting. Assignment of same-sex 
researchers will be employed if necessary; however, all study personnel 
will be trained to exhibit professional behavior and sensitivity when 
collecting personal health or medical data or when performing body 
composition or other testing.  
 
20.3 Describe how you plan to access existing sources of information about the 
subjects (e.g., medical records, grades) and how you will protect 
participant privacy through the data security plan: 
 
N/A 
 
20.4 Describe any required reporting that might occur as a result of your 
research questions, study populations, and data collection methods. 
Examples for Virginia and Virginia Tech include: 
• Any suspicions (e.g., circumstantial, disclosed) of child abuse (physical, 
emotional, sexual) and neglect  
• Sexual discrimination and/or sexual violence that involves a student 
• Disclosure or signs of intention to harm oneself (i.e., suicidal ideation 
and/or plan) 
• Disclosure or signs of desire to harm others (i.e., homicidal ideation 
and/or plan) 
• Suspected abuse, neglect or exploitation of vulnerable adults (e.g., 
individuals with a disability, elderly persons) 
 
 
N/A 
 
 
 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Safety monitoring is required when research involves greater than minimal risk 
and is sometimes appropriate for other studies. 
21.1 Describe: 

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● 
The plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe  (e.g., 
periodic reporting to the IRB, establishing a data monitoring 
committee, reporting data monitoring committee findings to the IRB 
and the sponsor). 
● 
What data you will review, including safety data, unexpected events, 
and data that show the ability to produce the intended results. 
● 
How the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with subjects). 
● 
The frequency of data collection, including when safety data 
collection starts. 
● 
Who will review the safety data and with what frequency. 
● 
The statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
● 
Any conditions that will trigger an immediate suspension of the 
research (e.g., a serious adverse event). 
 
 
 
The data safety monitoring plan (DSMP) for this study focuses on close monitoring by 
the principal investigator (PI) and research staff along with prompt reporting of excessive 
adverse events and any serious adverse events (AEs) to the Institutional Review Board. 
All serious AEs will be reported by the PI within 48 hours of occurrence to the IRB and 
the sponsor. 
  
The safety data monitored will include data related to the blood collections, exercise 
testing and the supervised resistance training sessions. Specific safety data include any 
reports of pain, excess swelling, redness or bruising after the blood draws at the needle 
insertion site, feelings of light headedness, chest tightness or pain or fatigue on exertion 
during exercise testing procedures, and symptoms of muscle soreness, joint pain, stiffness 
or unexpected events/issues during the 12 weeks of resistance training.  Data will be 
collected and documented in the participant’s chart if a situation arises or when observed 
by a member of the research team or reported by a participant during a study visits or 
during supervised resistance training sessions using a general TBD incident reporting 
form. Safety data will also include excessive changes in blood pressure or weight gain 
that will be measured during each scheduled study visit, and changes in blood glucose or 
serum cholesterol that will measured at the beginning and end of the study. 
 
The Project Coordinator (Elaina Marinik, Ph.D.) will be responsible for assembling the 
data and producing these reports as well as assuring that all parties obtain copies of these 
reports. Reports will be submitted annually to the VT IRB for review. 
  
Safety Data collection will start when the first participant is screened and enrolled. The 
study team will be informed to discuss any observed or reported unusual, excessive or 
unexpected events immediately with the PI.  The PI and/or study coordinator will review 
study charts and ongoing data collected on all participants on a weekly basis to ensure 

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safety. In our small study, it is unlikely that use of statistics would be necessary to 
determine if excessive events were occurring; however, paired t-tests could be used if 
appropriate (i.e. for blood pressure, blood glucose or serum cholesterol data).  We do not 
anticipate that there would be any specific events, other than the unexpected, that would 
trigger the suspension of our study,  
 
 
 
22.0 Compensation for Research Related Injury 
22.1 If the research involves more than minimal risk to subjects, describe the 
available compensation in the event of research-related injury, if any: 
 
Participants will not be provided any form of compensation for medical 
treatment or other damages (for example lost wages, time lost from work, 
etc.). If a participant becomes injured or sick from the research, they will 
be referred to a clinic or to their personal health care provider. Medical 
treatment may be provided at their expense or at the expense of their 
insurance company.  
 
22.2 Provide a copy of contract language, if any, relevant to compensation for 
research-related injury. At Virginia Tech, this is most common for 
sponsored research: 
 
I do not believe this applies 
 
23.0 Economic Burden to Subjects 
23.1 Describe any costs that subjects might be responsible for because of 
participation in the research, including any uncompensated costs for items 
such as transportation, missed work, and childcare: 
 
The participant will be responsible for costs that may include purchase of 
athletic clothes or shoes to participate in the resistance training sessions or 
the uncompensated cost that might include transportation, missed work or 
childcare. 
 
24.0 Consent Process 
24.1 Indicate the process by which you will obtain consent for study 
participation. Please upload all consent, parental permission, and assent 

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forms, documents, and scripts referenced in this section to Protocol 
Management. 
Describe the following: 
● 
Where the consent process will take place (e.g., clinic waiting area, 
classroom, online) 
● 
The time interval between sharing the consent information with the 
prospective subject and obtaining consent. For lab, interview, and 
focus group studies, the Virginia Tech IRB prefers that subjects have 
at least 24 hours to review the consent form and study information 
before the appointment where consent will be obtained. For simple 
online survey studies, you can typically present the consent 
information immediately before subjects begin participation. 
● 
If applicable, processes to ensure ongoing consent or assent (e.g., 
for multiple sessions; for research in which a minor will turn 18 
during the study; for longitudinal research with minors who will 
later be asked to provide or affirm their assent). 
● 
Please review “SOP: Informed Consent Process for Research (HRP-
090)” for recommended procedure. Describe your process, being 
sure to include: 
o 
The name and role of all study personnel who will be trained 
and certified by the PI to conduct the consent process 
o 
The time that will be devoted to the consent discussion 
o 
Steps that you will take to minimize the possibility of coercion 
or undue influence 
o 
Steps that you will take to gauge or ensure the subjects’ 
understanding 
 
Participants will be first screened over the phone. The phone screening 
will include an overview of the study, the time commitment and the 
possible risks to participation. After explaining the study and before 
conducting the phone screen, a study team member will describe the 
purpose of the phone screen and what type of data will be collected, and 
then ask that the participant provide verbal permission to conduct the 
phone screening.  They will also be informed that they may refuse to 
answer any and all questions. An informed consent form will be emailed 
(or mailed) to the participant following the phone screening and at least 24 
hours in advance of coming to the laboratory for the screening visit.   
At the start of the screening visit, a team member will provide potential 
participants with a written copy of the study consent form and review the 
document with the participant. Participants will be encouraged to ask 
questions and seek clarification during the phone screening. The 
participant will then be encouraged to ask questions before providing 
written consent. As much time as necessary will be devoted to address 
participant concerns.  Once the participant is ready to sign, he/she will be 

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allowed to sign in a private room near the door where they may also exit 
the lab if they no longer wish to participate. Screening and informed 
consent will be performed by the study coordinator or the doctoral student 
in charge of the study (A. Sanchez). Participants will be encouraged to ask 
questions and seek clarification during the phone screening and before 
signing the consent at the beginning of the laboratory screening visit. 
These steps including time to review the consent before the screening 
visit, time with study staff to review the protocol and address concerns, 
and time to sign the consent in a private setting and close to a laboratory 
exit will help minimize the possibility of coercion or undue influence.  
To help gauge the participant’s understanding, the team member will ask the 
participant to explain the study, how often they will be asked to consume 
the peanut or high-carbohydrate snacks, how many times a week they 
would need to come to the lab to resistance train and how many lab visits 
are expected.   
Non-English Speaking Subjects 
● 
Indicate what language(s) other than English are understood by 
prospective subjects or representatives. 
● 
If non-English speakers will be recruited, describe the process you 
will use to ensure that the oral and/or written consent information 
provided will be in a language that they understand.  
● 
If you translate consent forms and study materials, please provide a 
certified translation of the form as well as the certification 
document. 
● 
Indicate the spoken language that study personnel obtaining consent 
will use. Describe how you will assess fluency of personnel obtaining 
consent to ensure that the translation is accurate. 
 
 
Non-English speakers will not be recruited for the study. 
 
 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
● 
Review the “CHECKLIST: Waiver or Alteration of Consent Process 
(HRP-410)” to ensure you have provided sufficient information for 
the IRB to make these determinations (i.e., that it meets the criteria 
for a waiver or alteration of the consent process). 
 
N/A 
 

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Subjects who are not yet adults (minors: infants, children, teenagers) 
● 
Describe the criteria that you will use to determine  legal age for 
consent to treatments or procedures involved in the research under 
the applicable law of the jurisdiction in which the research will be 
conducted (e.g., in Virginia, individuals under the age of 18 years). 
o 
For research conducted in Virginia, review “SOP: Legally 
Authorized Representatives, Minors, and Guardians (HRP-
013)” to determine which individuals in the state meet the 
definition of “minor.” 
o 
For research conducted outside of the state, please describe 
the legal requirements for the definition of “minor.”  
● 
Describe the process for obtaining parental permission.  
o 
Permission from one parent is acceptable for studies that 
involve no greater than minimal risk OR involve greater than 
minimal risk but present the prospect of direct benefit to the 
minor subject. 
o 
Permission from both parents is required in all other 
cases (unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only 
one parent has legal responsibility for the care and 
custody of the minor). 
● 
Describe whether you will obtain permission from individuals other 
than parents or Legally Authorized Representatives, and if so, who 
will be allowed to provide permission. Describe the process you will 
use to determine these individuals’ authority to consent to the 
minor’s general medical care. 
● 
Indicate whether you will obtain assent from all, some, or none of 
the minors. If you will obtain assent from some minors, indicate 
which minors will be required to assent. Consider chronological age 
and intellectual capacity when determining who will be required to 
provide assent (e.g., infants are unable to assent. However, 
teenagers are likely able to read and sign an assent form). 
● 
When assent of minors is obtained, describe whether and how you 
will document it.  Will minors sign an assent form or give verbal 
assent? 
● 
Attach parental permission and minor assent forms or scripts in 
Protocol Management.  
 
 
N/A 
 
 
Adults Unable to Consent  

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● 
Describe the process you will use to determine whether an individual 
adult is capable of consent. 
● 
List the individuals from whom you will obtain permission in order 
of priority (e.g., durable power of attorney for health care, court 
appointed guardian for health care decisions, spouse, and non-
minor child). 
o 
For research conducted in the Virginia, review “SOP: Legally 
Authorized Representatives, Minors, and Guardians (HRP-
013)” to determine which individuals in the state meet the 
definition of “legally authorized representative.” 
o 
For research conducted outside of Virginia, please describe 
the legal requirements for obtaining permission from a legally 
authorized representative in the state where the research will 
occur. 
● 
Describe the process for assent of the subjects. 
o 
Indicate whether you will require assent from all, some, or 
none of the subjects. If some, indicate which subjects will be 
required to assent and which will not. 
o 
If you will not obtain assent from some or all subjects, please 
provide justification for not obtaining assent. 
o 
Describe whether and how you will document assent.  
N/A 
 
25.0 Process to Document Consent in Writing 
25.1 Consult “SOP: Written Documentation of Consent (HRP-091)” for 
recommended procedures, and describe whether and how consent of the 
subject will be documented in writing: 
 
Individuals who respond to the advertisements will be contacted by phone where they 
will be informed of the general plan of the study and all specific procedures included in 
the study (previously outlined in section 12). Participants will then be given a chance to 
ask questions regarding study procedures and risks.  Those still interested will be 
screened over the phone to determine eligibility based on desire to gain weight, current 
exercise history, dietary restrictions, medication use, history of food allergy, and other 
criteria outlined in section 12.2 (see uploaded Screening form). Eligible individuals will 
be sent a copy of the consent form via email to review prior to coming to the lab.  They 
will then be given a chance to ask any questions either by email or during their scheduled 
screening/baseline visit. Those still interested will be asked to sign the consent during 
their first visit, before any data is collected. This information is detailed in section 24 
above. A copy of the informed consent will be sent to all participants.  
 

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25.2 If the research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written documentation of consent is 
normally required outside of the research context, you can request that the 
IRB waive the requirement to obtain written documentation of consent 
(e.g., consent to participate is indicated by pressing a button for an online 
questionnaire – after the consent information is presented and before the 
questionnaire begins): 
 
Waiver of written consent to perform the phone screening is requested.  
The phone screening form has been uploaded.  
 
25.3 If you will document consent in writing, attach a consent document with 
places for signatures. If you will obtain consent, but not document consent 
in writing, please attach the consent script or text. Review “CHECKLIST: 
Waiver of Written Documentation of Consent (HRP-411)” to ensure that 
you have provided sufficient information. You should use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent document or 
script: 
 
See the attached participant consent form 
 
 
 
26.0 Resources Available 
26.1 Describe the resources available to conduct the research. For example, as 
appropriate: 
● 
Describe the PI’s availability to supervise the research. 
● 
Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period. For example, how 
many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? 
● 
Describe the time that you will devote to conducting and completing 
the research. 
● 
Describe your facilities. 
● 
Describe the availability of medical or psychological resources that 
subjects might need as a result of an anticipated or unanticipated 
consequence of participation in the research. 
● 
Describe your process to ensure that all persons assisting with the 
research are adequately informed about the protocol, the research 
procedures, and their duties and functions (e.g., training plans, 
detailed study notebooks). 
 

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The PI is a Professor in the Department of Human Nutrition, Foods and Exercise at 
Virginia Tech. She currently has a 33% research appointment and will oversee four 
doctoral students in the fall. She has previously served as a research dietitian and research 
exercise scientist at the National Institute of Diabetes & Digestive & Kidney Diseases in 
Phoenix and the Pennington Biomedical Research Center in Baton Rouge, LA, 
respectively, and has experience conducting exercise training studies and controlled 
feeding trials.  The PI and Co-investigator will dedicate time to this study as well as the 
study coordinator, Dr. Marinik, and two doctoral students, Jake Reynolds and Allison 
Sanchez.  Jake is an ACSM certified personal fitness trainer and Allison is an Army 
officer and registered dietitian nutritionist or RDN. The investigators have used the 
following laboratories at Virginia Tech where the research will take place.  In addition, 
the Department has secured space for Dr. Larson-Meyer’s NEM Laboratory on Kraft 
Drive close to the HIP Laboratory.  
 
The Laboratory for Eating Behaviors and Weight Management (Director: B. 
Davy) is located in Wallace Hall and encompasses a ~600 sq ft Metabolic Kitchen with a 
~900 sq ft research Dining Laboratory area and a research dietitian computer workstation 
(for dietary analysis software), reach-in freezer, and refrigerator for storing meals to be 
consumed off-site, and an additional ~250 sq ft space housing stadiometers, scales, tables 
for completing questionnaires, a private room for measuring blood pressure and 
anthropometrics, and a file storage area.  
 
The Human Integrative Physiology Laboratory is housed in both Wallace Hall 
(Body Composition Laboratory, Resting and Exercise Testing Laboratory (DE Larson-
Meyer)) and The Garvin Innovation Center (Exercise training equipment) located within 
a 5 min-drive from Wallace Hall. Major equipment items in the Body Composition and 
Resting and Exercise Testing Laboratories include two DXAs, Harpenden skinfold 
calipers, anthropometric tape measures, Parvomedics TrueOne 2400 metabolic cart, 
hospital bed, reclining phlebotomy chairs, Woodway treadmill, and blood pressure 
monitors. Additional research space is also available in Wallace Hall for sample 
processing (i.e., wet lab areas) and storage (-80 freezers). The Garvin space houses the 7-
piece Nautilus equipment, weight bench and two dumbbell sets in a 650 sq ft room with 
ample space for training, and free parking for participants. Restrooms, showers and 
changing facilities are also available.   
 
The Metabolic Core at Virginia Tech will perform the majority of the biochemical 
analyses. This core laboratory is housed in the Integrated Life Sciences building and 
includes a 140 sq ft. laboratory space dedicated to biochemical assays. This Core 
laboratory has a BioTek Synergy 2, a multi-mode microplate reader equipped with Gen5 
software capable of measurements of absorbance utilizing a monochrometer for 
wavelength selection from 200nm to 999nnm, and for fluorescence with excitation and 
emission filters for luminescence using a liquid-filled light guide 
 
 
27.0 Multi-Site Research 
Contact the HRPP for multi-site research (involving multiple institutions) and 
the details required for this section will be provided. Otherwise, indicate N/A. 

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N/A