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

July 19, 2017 updated by: United States Army Research Institute of Environmental Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Camp Lejeune, North Carolina, United States, 28546
        • US Marine SERE School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Self-reported allergies to dairy products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
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
Other Names:
  • Whey and Casein protein
  • Carbohydrate-based control
ACTIVE_COMPARATOR: Protein

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
Other Names:
  • Whey and Casein protein
  • Carbohydrate-based control
ACTIVE_COMPARATOR: High-Protein

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
Other Names:
  • Whey and Casein protein
  • Carbohydrate-based control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
days 1-2, days 18-19, and days 45-46

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Research Institute of Environmental Medicine

Investigators

  • Principal Investigator: Stefan M Pasiakos, Ph.D., USARIEM Military Nutrition Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

February 4, 2014

First Posted (ESTIMATE)

February 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-02H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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