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

NCT02057094 | Completed

• 1 other identifier: 14-02H
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Military Operational Stress Reaction; Malnutrition (Calorie); Weight Loss; Muscle Wasting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control

PLACEBO COMPARATOR

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

Protein

ACTIVE COMPARATOR

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

High-Protein

ACTIVE COMPARATOR

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

Interventions

Protein, High-Protein, and Control DIETARY_SUPPLEMENT

Also known as: Whey and Casein protein, Carbohydrate-based control

Control; High-Protein; Protein

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Self-reported allergies to dairy products

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

US Marine SERE School

Marine Corps Base Camp Lejeune, North Carolina, 28546, United States

Location

Related Publications (2)

• 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.

  PMID: 28385919 BACKGROUND

• 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.

  PMID: 36117330 DERIVED

MeSH Terms

Conditions

Malnutrition; Weight Loss; Muscular Atrophy

Interventions

Proteins; Whey

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Stefan M Pasiakos, Ph.D.

  USARIEM Military Nutrition Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: February 6, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 21, 2017

Record last verified: 2015-04

Locations

US (1)