Skip to main content
OpenTrials
Completed

NCT Number: NCT01714479

Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Muscle Loss Atrophy Muscle Anabolism Muscle Performance Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leucine-enriched nutritional supplement

Other

A protein and carbohydrate supplement with high levels of leucine

Placebo

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

  • US Army Natick Soldier Research, Development & Engineering Center

Registry information

Official study title

Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2012
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.