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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057094
• Other study ID #: 14-02H
• Status: Completed
• Phase: N/A
• First received: December 5, 2013
• Last updated: July 19, 2017
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Self-reported allergies to dairy products

Related Conditions & MeSH terms

• Fractures, Stress
• Malnutrition
• Malnutrition (Calorie)
• Military Operational Stress Reaction
• Muscle Wasting
• Muscular Atrophy
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	US Marine SERE School	Camp Lejeune	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Berryman CE, Sepowitz JJ, McClung HL, Lieberman HR, Farina EK, McClung JP, Ferrando AA, Pasiakos SM. Supplementing an energy adequate, higher protein diet with protein does not enhance fat-free mass restoration after short-term severe negative energy balance. J Appl Physiol (1985). 2017 Jun 1;122(6):1485-1493. doi: 10.1152/japplphysiol.01039.2016. Epub 2017 Apr 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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