- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01714479
Skeletal Muscle Response to Amino Acids and Load Carriage Exercise
July 19, 2017 updated by: United States Army Research Institute of Environmental Medicine
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
Status
Completed
Conditions
Intervention / Treatment
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.
General Publications
- 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.
- 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 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.
- Margolis 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.
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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