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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057094
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine

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.


Condition or disease Intervention/treatment Phase
Military Operational Stress Reaction Malnutrition (Calorie) Weight Loss Muscle Wasting Dietary Supplement: Protein, High-Protein, and Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effect of Protein Supplementation on Lean Body Mass Recovery and Physiological Resilience Following Survive, Evade, Resist, Escape (SERE) School
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Self-reported allergies to dairy products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057094


Locations
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United States, North Carolina
US Marine SERE School
Camp Lejeune, North Carolina, United States, 28546
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
Investigators
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Principal Investigator: Stefan M Pasiakos, Ph.D. USARIEM Military Nutrition Division
Publications:
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Responsible Party: United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT02057094    
Other Study ID Numbers: 14-02H
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: April 2015
Additional relevant MeSH terms:
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Muscular Atrophy
Malnutrition
Weight Loss
Fractures, Stress
Body Weight Changes
Body Weight
Nutrition Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Fractures, Bone
Wounds and Injuries
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action