Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

Muscle Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714479
• Other study ID #: 12-18-HC
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: July 19, 2017
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: September 2016
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Anabolism
• Muscle Loss
• Muscle Performance

Intervention

Other:
• Leucine-enriched nutritional supplement
A protein and carbohydrate supplement with high levels of leucine
• Placebo

Locations

Country	Name	City	State
United States	US Army Research Institute of Environmental Medicine	Natick	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine	US Army Natick Soldier Research, Development & Engineering Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Margolis LM, McClung HL, Murphy NE, Carrigan CT, Pasiakos SM. Skeletal Muscle myomiR Are Differentially Expressed by Endurance Exercise Mode and Combined Essential Amino Acid and Carbohydrate Supplementation. Front Physiol. 2017 Mar 23;8:182. doi: 10.3389/fphys.2017.00182. eCollection 2017. — View Citation

Pasiakos SM, McClung HL, Margolis LM, Murphy NE, Lin GG, Hydren JR, Young AJ. Human Muscle Protein Synthetic Responses during Weight-Bearing and Non-Weight-Bearing Exercise: A Comparative Study of Exercise Modes and Recovery Nutrition. PLoS One. 2015 Oct — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation		90 min exercise bout (exercise) and 180 min of recovery
Secondary	Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation		4, 24, 48, and 72 hours post exercise

External Links

•   Ingesting a Combined Carbohydrate and Essential Amino Acid Supplement Compared to a Non-Nutritive Placebo Blunts Mitochondrial Biogenesis-Related Gene Expression after Aerobic Exercise