Skeletal Muscle Response to Amino Acids and Load Carriage Exercise
Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 23, 2012
CompletedFirst Posted
Study publicly available on registry
October 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJuly 21, 2017
September 1, 2016
1.1 years
October 23, 2012
July 19, 2017
Conditions
Outcome Measures
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
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
4, 24, 48, and 72 hours post exercise
Study Arms (4)
Load Carriage - Control
PLACEBO COMPARATORLoad Carriage - with a calorie-free placebo
Load Carriage - leucine-enriched nutrition supplement
EXPERIMENTALLoad Carriage with leucine-enriched amino acid supplementation
Conventional Exercise - Control
PLACEBO COMPARATORConventional Exercise with a calorie-free placebo
Conventional Exercise - Leucine-enriched Nutrition Supplement
ACTIVE COMPARATORConventional Exercise with leucine-enriched Amino Acid supplementation
Interventions
A protein and carbohydrate supplement with high levels of leucine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760, United States
Related Publications (3)
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.
PMID: 28386239BACKGROUNDPasiakos 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 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.
PMID: 26474292RESULTMargolis LM, Murphy NE, Carrigan CT, McClung HL, Pasiakos SM. Ingesting a Combined Carbohydrate and Essential Amino Acid Supplement Compared to a Non-Nutritive Placebo Blunts Mitochondrial Biogenesis-Related Gene Expression after Aerobic Exercise. Curr Dev Nutr. 2017 May 23;1(6):e000893. doi: 10.3945/cdn.117.000893. eCollection 2017 Jun.
PMID: 29955707DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan M Pasiakos, Ph.D.
United States Army Research Institute of Environmental Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2012
First Posted
October 26, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
July 21, 2017
Record last verified: 2016-09