Weight GainmGAINSNCT05426109
Role of Peanuts in Healthy Weight Gain in Athletic Individuals
A study testing Peanut snacks and No peanut-containing snacks in people with Weight Gain, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Peanut snacks and No peanut-containing snacks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
About this study
Official title: 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.
- Conditions
- Weight Gain
- Being tested
- Peanut snacks, No peanut-containing snacks
- Keywords
- Hypercaloric diet, Weight training, Lean mass, Body composition
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut snacksOther
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.
No peanut-containing snacksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peanut snacks | Experimental | Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks. Receives: Other: Peanut snacks |
| No peanut-containing snacks | Active comparator | Participants will be provided and consume an extra 500 kcal/day of snacks without peanuts or peanut-containing foods for 10 weeks. Receives: Other: No peanut-containing snacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-min laboratory measurement assessed at the baseline, 3-wk, 7-wk, and 11-week test sessions.
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 (kg).
Measured: 10-min laboratory measurement assessed at the baseline, 3-wk, 7-wk and 11-week test sessions.
Secondary outcomes (3)
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.
Measured: 60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions.
Change in Testosterone Levels
Participants will have their blood collected by venipuncture in aseptic conditions. Testosterone (free) will be measured to determine the impact of the extra daily 500 kcal snacks on anabolism and muscle growth.
Measured: 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
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.
Measured: 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start22 Nov 2021
- Primary completion10 Nov 2022
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawnine Enette Larson-Meyer, Virginia Polytechnic Institute and State University
- Investigators
- Enette Larson-Meyer, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426109
- Sponsor's protocol ID
- 21-561
- Acronym
- mGAINS
- Status last verified
- May 2025
- First submitted
- 15 Jun 2022
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sanchez AD, Reynolds JC, Marinik EL, Kolb RD, Lozano AJ, Davy BM, Hunter GR, Larson-Meyer DE. A Randomized Trial of Healthy Weight Gain in Athletic Individuals. Med Sci Sports Exerc. 2024 Aug 1;56(8):1454-1466. doi: 10.1249/MSS.0000000000003427. Epub 2024 Mar 23.
PubMed 38537251
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Peanuts in Enhancing Healthy Weight Gain in Athletic Individuals
- ClinicalTrials.gov ID
- NCT05426109
- Acronym / sponsor ID
- mGAINS / 21-561
- Conditions
- Weight Gain
- Keywords
- Hypercaloric diet, Weight training, Lean mass, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut snacks | Experimental | Other: Peanut snacksParticipants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks. |
| No peanut-containing snacks | Active comparator | Other: No peanut-containing snacksParticipants will be provided and consume an extra 500 kcal/day of snacks without peanuts or peanut-containing foods for 10 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut snacksParticipants 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. | Other | Peanut snacks |
| No peanut-containing snacksParticipants 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. | Other | No peanut-containing snacks |
Primary outcome
Change in Total Body Mass (Weight)
Time frame: 1-min laboratory measurement assessed at the baseline, 3-wk, 7-wk, 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.
Change in Lean Body Mass
Time frame: 10-min laboratory measurement assessed at the baseline, 3-wk, 7-wk 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 (kg).
3 secondary outcomes
Change in Resting Metabolic Rate
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38537251Sanchez AD, Reynolds JC, Marinik EL, Kolb RD, Lozano AJ, Davy BM, Hunter GR, Larson-Meyer DE. A Randomized Trial of Healthy Weight Gain in Athletic Individuals. Med Sci Sports Exerc. 2024 Aug 1;56(8):1454-1466. doi: 10.1249/MSS.0000000000003427. Epub 2024 Mar 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enette Larson-Meyer, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut snacks and No peanut-containing snacks in people with Weight Gain, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Body Mass (Weight) (time frame: 1-min laboratory measurement assessed at the baseline, 3-wk, 7-wk, and 11-week test sessions.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.