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

Primary Purpose

Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein, High-Protein, and Control
Sponsored by
United States Army Research Institute of Environmental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Military Operational Stress Reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • US Marine SERE School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control

Protein

High-Protein

Arm Description

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

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 5, 2013
Last Updated
July 19, 2017
Sponsor
United States Army Research Institute of Environmental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02057094
Brief Title
Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training
Official Title
Effect of Protein Supplementation on Lean Body Mass Recovery and Physiological Resilience Following Survive, Evade, Resist, Escape (SERE) School
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss, Muscle Wasting

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Dining facility recovery feeding only, no supplemental protein consumed (an isoenergetic, carbohydrate supplement will be consumed by those assigned to the Control group)
Arm Title
Protein
Arm Type
Active Comparator
Arm 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)
Arm Title
High-Protein
Arm Type
Active Comparator
Arm Description
Consume dining facility food with: 2, 40 g whey protein supplements daily (~27 days) 1, 50 g casein protein supplement daily (~27 days)
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein, High-Protein, and Control
Other Intervention Name(s)
Whey and Casein protein, Carbohydrate-based control
Primary Outcome Measure Information:
Title
Change in lean body mass following SERE and recovery nutrition
Description
Days 1-2: baseline Days 18-19: completion of SERE training Days 45-46: completion of a 26 day recovery nutrition intervention
Time Frame
days 1-2, days 18-19, and days 45-46

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: US Marines at least 18 years old, enrolled in US Marine SERE school Exclusion Criteria: Self-reported allergies to dairy products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan M Pasiakos, Ph.D.
Organizational Affiliation
USARIEM Military Nutrition Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Marine SERE School
City
Camp Lejeune
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28385919
Citation
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.
Results Reference
background
PubMed Identifier
36117330
Citation
Berryman CE, McClung HL, Sepowitz JJ, Gaffney-Stomberg E, Ferrando AA, McClung JP, Pasiakos SM. Testosterone status following short-term, severe energy deficit is associated with fat-free mass loss in U.S. Marines. Physiol Rep. 2022 Sep;10(18):e15461. doi: 10.14814/phy2.15461.
Results Reference
derived

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

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