Role of Peanuts in Healthy Weight Gain in Athletic Individuals (mGAINS)
Primary Purpose
Weight Gain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peanut snacks
No peanut-containing snacks
Sponsored by
About this trial
This is an interventional treatment trial for Weight Gain focused on measuring Hypercaloric diet, Weight training, Lean mass, Body composition
Eligibility Criteria
Inclusion Criteria:
- Interested in gaining 5 pounds of body weight to enhance effectiveness in sport, fitness, or military training/competition.
- Willing to eat 500 kcal/d and weight train 3x/wk for 10 weeks
- Have weight trained in the past 12 months
- Not taking medications or dietary supplements that influence study results
- Non-smoker
- Without any major medical problems (including high blood pressure or coronary heart disease)
Exclusion Criteria:
- Nut, peanut, tree nut or legume allergy
- No weight training experience
- Orthopedic limitations that affect ability to weight train
- Currently taking dietary supplements or prescribed pharmacological agents that may affect lean tissue accretion
- Current or past anabolic steroid use
- Have a history of or current signs of disordered eating
- Pregnant
- Abnormal levels of thyroid stimulating hormone or hemoglobin, serum lipids (e.g., fasting triglycerides >150 mg/dL and/or total cholesterol >200 mg/dL)
Sites / Locations
- Virginia Polytechnic Institute and State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peanut snacks
No peanut-containing snacks
Arm Description
Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks.
Participants will be provided and consume an extra 500 kcal/day of snacks without peanuts or peanut-containing foods for 10 weeks.
Outcomes
Primary Outcome Measures
Change in Total Body Mass (Weight)
Participants will be weighed on a digital scale wearing standardized lab clothes at all scheduled testing sessions throughout the study.
Change in Lean Body Mass
Participants will undergo a dual-energy x-ray absorptiometry scan wearing standardized lab clothing at all scheduled testing sessions throughout the study. The scan analysis provides body composition results, including lean (fat-free) mass to the closest gram.
Secondary Outcome Measures
Change in Resting Metabolic Rate
Participants will undergo a resting metabolic rate (RMR) test during select testing sessions throughout the study. The indirect calorimetry test measures the daily energy expenditure (or number of kilocalories needed to perform and maintain daily bodily functions) of each participant based on the measured gas exchange during the test.
Change in Testosterone Levels
Participants will have their blood collected by venipuncture in aseptic conditions. Testosterone (free and total) will be measured to determine the impact of the extra daily 500 kcal snacks on anabolism and muscle growth.
Change in Insulin-Like Growth Factor Levels
Participants will have their blood collected by venipuncture in aseptic conditions. Insulin-like growth factor (IGF) will be measured to determine the impact of the extra daily 500 kcal snacks on anabolism and muscle growth.
Full Information
NCT ID
NCT05426109
First Posted
June 15, 2022
Last Updated
May 24, 2023
Sponsor
Virginia Polytechnic Institute and State University
1. Study Identification
Unique Protocol Identification Number
NCT05426109
Brief Title
Role of Peanuts in Healthy Weight Gain in Athletic Individuals
Acronym
mGAINS
Official Title
Exploring the Role of Peanuts in Enhancing Healthy Weight Gain in Athletic Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many athletes and military personnel desire weight gain primarily as lean mass to improve performance and effectiveness in military/sport endeavors. While much is known about the energy restriction required to reduce body weight, very little is understood about energy and macronutrients needed to promote healthy gains in body weight and lean mass. Typically, athletes are encouraged to increase calorie intake by ~500 kcal/day with an emphasis on adequate protein and carbohydrate, and judicious inclusion of healthy fat-containing calorically-dense foods, including peanuts and peanut butter. This study proposes to evaluate the effect of a 10-week diet and exercise regimen designed to promote healthy 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 strength training regimen. Results will serve as an important first step in helping understand the gaps in knowledge related to healthy weight gain, designing better weight gain meal plans, not only in athletes and military personnel, but also in clinical populations where promotion of weight gain is advocated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
Hypercaloric diet, Weight training, Lean mass, Body composition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Both the investigators and participants are aware of the group assignment since the foods prepared and provided (peanut-containing or no peanut snacks) cannot be masked.
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peanut snacks
Arm Type
Experimental
Arm Description
Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks.
Arm Title
No peanut-containing snacks
Arm Type
Active Comparator
Arm Description
Participants will be provided and consume an extra 500 kcal/day of snacks without peanuts or peanut-containing foods for 10 weeks.
Intervention Type
Other
Intervention Name(s)
Peanut snacks
Intervention Description
Participants will undergo a 10-week diet and weight training regimen to promote healthy weight gain. These participants will receive seven 500 kcal peanut-containing (whole peanuts or peanut butter) snacks each week and consume one snack per day throughout the study. They will also perform a series of weight training exercises supervised by a personal trainer on 3 days per week.
Intervention Type
Other
Intervention Name(s)
No peanut-containing snacks
Intervention Description
Participants will undergo a 10-week diet and weight training regimen to promote healthy weight gain. These participants will receive seven 500 kcal non-peanut-containing high carbohydrate snacks each week and consume one snack per day throughout the study. They will also perform a series of weight training exercises supervised by a personal trainer on 3 days per week.
Primary Outcome Measure Information:
Title
Change in Total Body Mass (Weight)
Description
Participants will be weighed on a digital scale wearing standardized lab clothes at all scheduled testing sessions throughout the study.
Time Frame
1-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
Title
Change in Lean Body Mass
Description
Participants will undergo a dual-energy x-ray absorptiometry scan wearing standardized lab clothing at all scheduled testing sessions throughout the study. The scan analysis provides body composition results, including lean (fat-free) mass to the closest gram.
Time Frame
10-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
Secondary Outcome Measure Information:
Title
Change in Resting Metabolic Rate
Description
Participants will undergo a resting metabolic rate (RMR) test during select testing sessions throughout the study. The indirect calorimetry test measures the daily energy expenditure (or number of kilocalories needed to perform and maintain daily bodily functions) of each participant based on the measured gas exchange during the test.
Time Frame
60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions.
Title
Change in Testosterone Levels
Description
Participants will have their blood collected by venipuncture in aseptic conditions. Testosterone (free and total) will be measured to determine the impact of the extra daily 500 kcal snacks on anabolism and muscle growth.
Time Frame
5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
Title
Change in Insulin-Like Growth Factor Levels
Description
Participants will have their blood collected by venipuncture in aseptic conditions. Insulin-like growth factor (IGF) will be measured to determine the impact of the extra daily 500 kcal snacks on anabolism and muscle growth.
Time Frame
5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Interested in gaining 5 pounds of body weight to enhance effectiveness in sport, fitness, or military training/competition.
Willing to eat 500 kcal/d and weight train 3x/wk for 10 weeks
Have weight trained in the past 12 months
Not taking medications or dietary supplements that influence study results
Non-smoker
Without any major medical problems (including high blood pressure or coronary heart disease)
Exclusion Criteria:
Nut, peanut, tree nut or legume allergy
No weight training experience
Orthopedic limitations that affect ability to weight train
Currently taking dietary supplements or prescribed pharmacological agents that may affect lean tissue accretion
Current or past anabolic steroid use
Have a history of or current signs of disordered eating
Pregnant
Abnormal levels of thyroid stimulating hormone or hemoglobin, serum lipids (e.g., fasting triglycerides >150 mg/dL and/or total cholesterol >200 mg/dL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enette Larson-Meyer, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Polytechnic Institute and State University
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24061
Country
United States
12. IPD Sharing Statement
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Role of Peanuts in Healthy Weight Gain in Athletic Individuals
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