Weight Gain
Conditions
Keywords
Hypercaloric diet, Weight training, Lean mass, Body composition
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.
Interventions
OTHERPeanut 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.
OTHERNo 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.
Sponsors
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Body Mass (Weight) | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting Metabolic Rate | 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. |
| Change in Testosterone Levels | 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) 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Peanut Snacks | No Peanut-containing Snacks |
|---|---|---|---|
| Age, Continuous | 23 years | 23 years | 22 years |
| Race/Ethnicity, Customized Reported Race Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Reported Race Black/African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Reported Race Hispanic/Latino | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Reported Race Mixed (≥2 race categories) | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Reported Race White | 24 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 19 Participants | 10 Participants | 9 Participants |
| Total Body Mass | 69 kg STANDARD_DEVIATION 11.4 | 67.7 kg STANDARD_DEVIATION 12.7 | 70.4 kg STANDARD_DEVIATION 10.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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).
Time frame: 10-min laboratory measurement assessed at the baseline, 3-wk, 7-wk and 11-week test sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peanut Snacks | Change in Lean Body Mass | 11-wk | 1.2 kg | Standard Deviation 1.1 |
| Peanut Snacks | Change in Lean Body Mass | 7-wk | 1.5 kg | Standard Deviation 0 |
| Peanut Snacks | Change in Lean Body Mass | 3-wk | 0.8 kg | Standard Deviation 0.4 |
| No Peanut-containing Snacks | Change in Lean Body Mass | 11-wk | 1.9 kg | Standard Deviation 1 |
| No Peanut-containing Snacks | Change in Lean Body Mass | 7-wk | 1.7 kg | Standard Deviation 0 |
| No Peanut-containing Snacks | Change in Lean Body Mass | 3-wk | 1.1 kg | Standard Deviation 0.3 |
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.
Time frame: 1-min laboratory measurement assessed at the baseline, 3-wk, 7-wk, and 11-week test sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peanut Snacks | Change in Total Body Mass (Weight) | 7-wk | 1.8 kg | Standard Deviation 0.2 |
| Peanut Snacks | Change in Total Body Mass (Weight) | 3-wk | 0.8 kg | Standard Deviation 0.4 |
| Peanut Snacks | Change in Total Body Mass (Weight) | 11-wk | 1.6 kg | Standard Deviation 1.1 |
| No Peanut-containing Snacks | Change in Total Body Mass (Weight) | 11-wk | 2.7 kg | Standard Deviation 1.2 |
| No Peanut-containing Snacks | Change in Total Body Mass (Weight) | 7-wk | 2.2 kg | Standard Deviation 0.1 |
| No Peanut-containing Snacks | Change in Total Body Mass (Weight) | 3-wk | 1.2 kg | Standard Deviation 0.3 |
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.
Time frame: 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peanut Snacks | Change in Insulin-Like Growth Factor Levels | 11-wk | 51.3 ng/mL | Standard Deviation 21.4 |
| Peanut Snacks | Change in Insulin-Like Growth Factor Levels | 7-wk | 51.1 ng/mL | Standard Deviation 17.4 |
| Peanut Snacks | Change in Insulin-Like Growth Factor Levels | 3-wk | 47.9 ng/mL | Standard Deviation 20.2 |
| Peanut Snacks | Change in Insulin-Like Growth Factor Levels | baseline | 49.8 ng/mL | Standard Deviation 16.4 |
| No Peanut-containing Snacks | Change in Insulin-Like Growth Factor Levels | baseline | 49.6 ng/mL | Standard Deviation 14.2 |
| No Peanut-containing Snacks | Change in Insulin-Like Growth Factor Levels | 11-wk | 53.4 ng/mL | Standard Deviation 13.7 |
| No Peanut-containing Snacks | Change in Insulin-Like Growth Factor Levels | 3-wk | 45.0 ng/mL | Standard Deviation 16.4 |
| No Peanut-containing Snacks | Change in Insulin-Like Growth Factor Levels | 7-wk | 49.4 ng/mL | Standard Deviation 21.5 |
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.
Time frame: 60-min laboratory measurement assessed at the baseline, 3-week, and 11-week test sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peanut Snacks | Change in Resting Metabolic Rate | 11-wk | 1627 kcal/day | Standard Error 369 |
| Peanut Snacks | Change in Resting Metabolic Rate | 3-wk | 1595 kcal/day | Standard Error 253 |
| Peanut Snacks | Change in Resting Metabolic Rate | BSL | 1541 kcal/day | Standard Error 285 |
| No Peanut-containing Snacks | Change in Resting Metabolic Rate | 11-wk | 1717 kcal/day | Standard Error 338 |
| No Peanut-containing Snacks | Change in Resting Metabolic Rate | 3-wk | 1706 kcal/day | Standard Error 258 |
| No Peanut-containing Snacks | Change in Resting Metabolic Rate | BSL | 1632 kcal/day | Standard Error 262 |
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.
Time frame: 5-min laboratory measurement assessed at the baseline, 3-week, 7-week, and 11-week test sessions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peanut Snacks | Change in Testosterone Levels | 11-wk | 18.5 pg/mL | Standard Deviation 10.7 |
| Peanut Snacks | Change in Testosterone Levels | 7-wk | 19.0 pg/mL | Standard Deviation 10.2 |
| Peanut Snacks | Change in Testosterone Levels | baseline | 21.7 pg/mL | Standard Deviation 9.7 |
| Peanut Snacks | Change in Testosterone Levels | 3-wk | 18.5 pg/mL | Standard Deviation 9.5 |
| No Peanut-containing Snacks | Change in Testosterone Levels | baseline | 23.5 pg/mL | Standard Deviation 11.9 |
| No Peanut-containing Snacks | Change in Testosterone Levels | 11-wk | 20.0 pg/mL | Standard Deviation 10.3 |
| No Peanut-containing Snacks | Change in Testosterone Levels | 7-wk | 20.9 pg/mL | Standard Deviation 9.8 |
| No Peanut-containing Snacks | Change in Testosterone Levels | 3-wk | 21.4 pg/mL | Standard Deviation 11.3 |