Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02057094
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2013-12-05
Brief Title:
Effects of Protein Supplementation on Lean Body Mass Recovery From Extreme Military Training
Sponsor:
United States Army Research Institute of Environmental Medicine
Organization:
United States Army Research Institute of Environmental Medicine
Study Overview
Official Title:
Effect of Protein Supplementation on Lean Body Mass Recovery and Physiological Resilience Following Survive Evade Resist Escape SERE School
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None