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NCT02057094 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by United States Army Research Institute of Environmental Medicine.

Completed
Registry status
NA
Development phase
71
Enrollment target

NCT02057094 is a NA study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 71 participants.

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The verdict

NCT02057094, a NA study, has completed, sponsored by United States Army Research Institute of Environmental Medicine.

COMPLETED
Registry status
NA
Development phase
71 participants
Enrollment target

Study 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 th

Interventions

  • DIETARY_SUPPLEMENT Protein, High-Protein, and Control

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2014-01
Est. Completion 2015-03
Phase NA

What the Registry Record Tells You About NCT02057094

The ClinicalTrials.gov registry entry for NCT02057094 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Army Research Institute of Environmental Medicine, which has 59 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Protein, High-Protein, and Control is the first listed.

NCT02057094 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02057094 about?

NCT02057094 is a clinical study titled "Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training". 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 Cam...

What is the current status of trial NCT02057094?

This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2014-01. Estimated completion is 2015-03.

What interventions are being tested in trial NCT02057094?

The interventions under investigation include: Protein, High-Protein, and Control (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02057094?

This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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