Skip to main content
OpenTrials
Completed

NCT Number: NCT02057094

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Self-reported allergies to dairy products

Treatment and study plan

Protein, High-Protein, and Control

Dietary Supplement

Other names: Whey and Casein protein, Carbohydrate-based control

Primary outcomes

  1. Change in lean body mass following SERE and recovery nutrition

    Time frame: days 1-2, days 18-19, and days 45-46

    Days 1-2: baseline Days 18-19: completion of SERE training Days 45-46: completion of a 26 day recovery nutrition intervention

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2014
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.