Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

This study has been completed.
Sponsor:
Collaborator:
Combat Feeding Directorate, US Army Natick Soldier Research Development & Engineering Center
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01714479
First received: October 23, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. The typical assault load is approximately 25 kg, although loads as high as 55 kg are often carried, which when combined with extreme energy expenditures can degrade health and performance, and increase the risk of injury. Branched-chain amino acid (leucine) supplementation may confer protection against the negative effects of operational stress by stimulating muscle protein synthesis and reducing degradation. This study will determine if leucine-enriched nutrition supplementation confers protection against the negative consequences of sustained load carriage exercise, and explore the mechanisms by which leucine might impart protection.


Condition Intervention
Muscle Loss
Muscle Anabolism
Muscle Performance
Other: Leucine-enriched nutritional supplement
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage

Resource links provided by NLM:


Further study details as provided by United States Army Research Institute of Environmental Medicine:

Primary Outcome Measures:
  • Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation [ Time Frame: 90 min exercise bout (exercise) and 180 min of recovery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation [ Time Frame: 4, 24, 48, and 72 hours post exercise ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Load Carriage - Control
Load Carriage - with a calorie-free placebo
Other: Placebo
Experimental: Load Carriage - leucine-enriched nutrition supplement
Load Carriage with leucine-enriched amino acid supplementation
Other: Leucine-enriched nutritional supplement
A protein and carbohydrate supplement with high levels of leucine
Placebo Comparator: Conventional Exercise - Control
Conventional Exercise with a calorie-free placebo
Other: Placebo
Active Comparator: Conventional Exercise - Leucine-enriched Nutrition Supplement
Conventional Exercise with leucine-enriched Amino Acid supplementation
Other: Leucine-enriched nutritional supplement
A protein and carbohydrate supplement with high levels of leucine

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 - 60 ml/kg/min
  • Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®), or any aspirin-containing products, alchohol, and nicotine
  • Females must be on oral contraception

Exclusion Criteria:

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders
  • Disease or medication that affects macronutrient metabolism or the ability to participate in strenuous exercise
  • Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be used in the study
  • Anemia (HCT <38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with blood clotting
  • Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
  • Musculoskeletal injuries that compromise the ability to exercise
  • Blood donation within 8 weeks of enrollment
  • Pregnancy and women not on oral contraceptives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714479

Locations
United States, Massachusetts
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
Combat Feeding Directorate, US Army Natick Soldier Research Development & Engineering Center
Investigators
Principal Investigator: Stefan M Pasiakos, Ph.D. United States Army Research Institute of Environmental Medicine
  More Information

No publications provided

Responsible Party: United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT01714479     History of Changes
Other Study ID Numbers: 12-18-HC
Study First Received: October 23, 2012
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 22, 2014