Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

United States Army Research Institute of Environmental Medicine

Status: Completed

Conditions: Muscle Performance; Muscle Anabolism; Muscle Loss

Treatments: Other: Leucine-enriched nutritional supplement; Other: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT01714479

12-18-HC

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

Load Carriage - Control

Placebo Comparator group

Description:

Load Carriage - with a calorie-free placebo

Treatment:

Other: Placebo

Load Carriage - leucine-enriched nutrition supplement

Experimental group

Description:

Load Carriage with leucine-enriched amino acid supplementation

Treatment:

Other: Leucine-enriched nutritional supplement

Conventional Exercise - Control

Placebo Comparator group

Description:

Conventional Exercise with a calorie-free placebo

Treatment:

Other: Placebo

Conventional Exercise - Leucine-enriched Nutrition Supplement

Active Comparator group

Description:

Conventional Exercise with leucine-enriched Amino Acid supplementation

Treatment:

Other: Leucine-enriched nutritional supplement