Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Natick, Massachusetts, United States, 01760
        • US Army Research Institute of Environmental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Load Carriage - Control
Load Carriage - with a calorie-free placebo
Experimental: Load Carriage - leucine-enriched nutrition supplement
Load Carriage with leucine-enriched amino acid supplementation
A protein and carbohydrate supplement with high levels of leucine
Placebo Comparator: Conventional Exercise - Control
Conventional Exercise with a calorie-free placebo
Active Comparator: Conventional Exercise - Leucine-enriched Nutrition Supplement
Conventional Exercise with leucine-enriched Amino Acid supplementation
A protein and carbohydrate supplement with high levels of leucine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
90 min exercise bout (exercise) and 180 min of recovery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4, 24, 48, and 72 hours post exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stefan M Pasiakos, Ph.D., United States Army Research Institute of Environmental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 12-18-HC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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