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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut snacks | Experimental | Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut snacks | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 10-min laboratory measurement assessed at the baseline, 3-wk, 7-wk and 11-week test sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enette Larson-Meyer, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Polytechnic Institute and State University | Blacksburg | Virginia | 24061 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38537251 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peanut Snacks | Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks. Peanut snacks: 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. |
| FG001 | 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. No peanut-containing snacks: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peanut Snacks | Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks. Peanut snacks: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only included participants who completed the 10 wk intervention |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | kg | 1-min laboratory measurement assessed at the baseline, 3-wk, 7-wk, and 11-week test sessions. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peanut Snacks | Participants will be provided and consume an extra 500 kcal/day of peanut-containing snacks for 10 weeks. Peanut snacks: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Larson-Meyer | Virginia Tech | 540-231-1025 | enette@vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2024 | Nov 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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|
| No peanut-containing snacks | Other | 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. |
|
| 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. | 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. | 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions. |
| BG001 | 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. No peanut-containing snacks: 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. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Only including participants who completed the 10 week intervention | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Total Body Mass | Only including participants who completed the 10-week intervention | Mean | Standard Deviation | kg |
|
| 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. No peanut-containing snacks: 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 | 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). | Posted | Mean | Standard Deviation | kg | 10-min laboratory measurement assessed at the baseline, 3-wk, 7-wk and 11-week test sessions. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | kcal/day | 60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | pg/mL | 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mL | 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions. |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. No peanut-containing snacks: 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| 3-wk |
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| BSL |
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| 3-wk |
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| baseline |
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| 3-wk |
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| baseline |
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