Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the physiological consequences of extreme military training and determine whether protein supplementation enhances recovery by promoting gains in lean body mass. This study will be conducted at the US Marine Survive, Evade, Resist, Escape (SERE) school at Camp Lejeune, North Carolina. SERE school may be an ideal setting to assess nutritional interventions that promote recovery from severe military operational stress, and identify innate or experiential variables that may lead to increased levels of resilience in Warfighters. Our laboratory has recently demonstrated the detrimental effects and stressful nature of SERE. Heart rates and stress-related hormones increased dramatically, with concomitant reductions in circulating anabolic hormones. Additionally, SERE causes significant weight loss (15-20 lbs), which probably included lean body mass. The effects of severe operational stress induced by SERE, particularly the loss of lean mass, may degrade physical performance, increase injury risk, and compromise military readiness. Under controlled laboratory conditions, consuming high protein diets or supplemental high-quality protein promotes muscle protein retention, enhances muscle protein synthesis, and protects lean body mass in response to stress. Whether consuming supplemental protein promotes lean mass recovery and physiological resilience following a 'real-world' military stress has not been determined. Further, the level of supplemental protein necessary to optimize recovery from extreme military operational stress has not been elucidated. Up to 90 US Marines will be enrolled in a 46-day double-blind, placebo-controlled trial. Using complex body composition measurements, kinetic modeling of human metabolism, blood sampling and cognitive and nutrition questionnaires, the consequences of SERE and the efficacy of protein recovery nutrition on lean mass accretion and Warfighter resilience will be assessed. We hypothesize that consuming a specially formulated, high-quality supplemental protein ration item will speed recovery of lean body mass, physiological, and psychological resilience following extreme military operational stress.

Official Title
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Effect of Protein Supplementation on Lean Body Mass Recovery and Physiological Resilience Following Survive, Evade, Resist, Escape (SERE) School

Conditions
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Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss, Muscle Wasting

Intervention / Treatment
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* Dietary Supplement: Protein, High-Protein, and Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: US Marines at least 18 years old, enrolled in US Marine SERE school Exclusion Criteria: Self-reported allergies to dairy products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Dining facility recovery feeding only, no supplemental protein consumed (an isoenergetic, carbohydrate supplement will be consumed by those assigned to the Control group) | Dietary Supplement: Protein, High-Protein, and Control<br> <br> * Other names: Carbohydrate-based control;|
| Active Comparator: Protein<br>Consume dining facility food with: 2, 20 g whey protein supplements daily (for  27 days) 1, 40 g casein protein supplement daily (for  27 days) | Dietary Supplement: Protein, High-Protein, and Control<br> <br> * Other names: Carbohydrate-based control;|
| Active Comparator: High-Protein<br>Consume dining facility food with: 2, 40 g whey protein supplements daily ( 27 days) 1, 50 g casein protein supplement daily ( 27 days) | Dietary Supplement: Protein, High-Protein, and Control<br> <br> * Other names: Carbohydrate-based control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lean body mass following SERE and recovery nutrition | Days 1-2: baseline Days 18-19: completion of SERE training Days 45-46: completion of a 26 day recovery nutrition intervention | days 1-2, days 18-19, and days 45-46 |