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

United States Army Research Institute of Environmental Medicine

Status: Completed

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

Treatments: Dietary Supplement: Protein, High-Protein, and Control

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02057094

14-02H

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• US Marines at least 18 years old, enrolled in US Marine SERE school

Exclusion criteria

• Self-reported allergies to dairy products

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Dining facility recovery feeding only, no supplemental protein consumed (an isoenergetic, carbohydrate supplement will be consumed by those assigned to the Control group)

Treatment:

Dietary Supplement: Protein, High-Protein, and Control

Protein

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Protein, High-Protein, and Control

High-Protein

Active Comparator group

Description:

Consume dining facility food with: 2, 40 g whey protein supplements daily (\~27 days) 1, 50 g casein protein supplement daily (\~27 days)

Treatment:

Dietary Supplement: Protein, High-Protein, and Control