- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426109
Role of Peanuts in Healthy Weight Gain in Athletic Individuals (mGAINS)
November 20, 2023 updated by: Dawnine Enette Larson-Meyer, Virginia Polytechnic Institute and State University
Exploring the Role of Peanuts in Enhancing Healthy Weight Gain in Athletic Individuals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
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Blacksburg, Virginia, United States, 24061
- Virginia Polytechnic Institute and State University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peanut snacks
Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks.
|
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.
|
Active Comparator: No peanut-containing snacks
Participants will be provided and consume an extra 500 kcal/day of snacks without peanuts or peanut-containing foods for 10 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Body Mass (Weight)
Time Frame: 1-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
|
Participants will be weighed on a digital scale wearing standardized lab clothes at all scheduled testing sessions throughout the study.
|
1-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
|
Change in Lean Body Mass
Time Frame: 10-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
|
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.
|
10-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Resting Metabolic Rate
Time Frame: 60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions.
|
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.
|
60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions.
|
Change in Testosterone Levels
Time Frame: 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
|
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.
|
5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
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Change in Insulin-Like Growth Factor Levels
Time Frame: 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
|
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.
|
5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Enette Larson-Meyer, PhD, Virginia Polytechnic Institute and State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2021
Primary Completion (Actual)
November 10, 2022
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
June 15, 2022
First Submitted That Met QC Criteria
June 15, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-561
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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