Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Muscle Loss Muscle Anabolism Muscle Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Load Carriage - Control

Load Carriage - with a calorie-free placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Load Carriage - leucine-enriched nutrition supplement

Load Carriage with leucine-enriched amino acid supplementation

Group Type EXPERIMENTAL

Leucine-enriched nutritional supplement

Intervention Type OTHER

A protein and carbohydrate supplement with high levels of leucine

Conventional Exercise - Control

Conventional Exercise with a calorie-free placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Conventional Exercise - Leucine-enriched Nutrition Supplement

Conventional Exercise with leucine-enriched Amino Acid supplementation

Group Type ACTIVE_COMPARATOR

Leucine-enriched nutritional supplement

Intervention Type OTHER

A protein and carbohydrate supplement with high levels of leucine

Interventions

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Leucine-enriched nutritional supplement

A protein and carbohydrate supplement with high levels of leucine

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes