Skeletal Muscle Response to Amino Acids and Load Carriage Exercise
This study is currently recruiting participants.
Verified October 2012 by United States Army Research Institute of Environmental Medicine
Sponsor:
United States Army Research Institute of Environmental Medicine
Collaborator:
Combat Feeding Directorate, US Army Natick Soldier Research Development & Engineering Center
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01714479
First received: October 23, 2012
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Muscle Loss Muscle Anabolism Muscle Performance |
Other: Leucine-enriched nutritional supplement Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Skeletal Muscle and Physical Performance Responses to Leucine-Enriched Nutrition Supplementation During Load Carriage |
Resource links provided by NLM:
Further study details as provided by United States Army Research Institute of Environmental Medicine:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Load Carriage - Control
Load Carriage - with a calorie-free placebo
|
Other: Placebo |
|
Experimental: Load Carriage - leucine-enriched nutrition supplement
Load Carriage with leucine-enriched amino acid supplementation
|
Other: Leucine-enriched nutritional supplement
A protein and carbohydrate supplement with high levels of leucine
|
|
Placebo Comparator: Conventional Exercise - Control
Conventional Exercise with a calorie-free placebo
|
Other: Placebo |
|
Active Comparator: Conventional Exercise - Leucine-enriched Nutrition Supplement
Conventional Exercise with leucine-enriched Amino Acid supplementation
|
Other: Leucine-enriched nutritional supplement
A protein and carbohydrate supplement with high levels of leucine
|
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714479
Contacts
| Contact: Stefan M Pasiakos, Ph.D. | 508-233-6474 | stefan.pasiakos@us.army.mil |
| Contact: Holly L McClung, M.S. | 508-233-5309 | holly.l.mcclung@us.army.mil |
Locations
| United States, Massachusetts | |
| US Army Research Institute of Environmental Medicine | Recruiting |
| Natick, Massachusetts, United States, 01760 | |
| Contact: Stefan M Pasiakos, Ph.D. 508-233-6474 stefan.pasiakos@us.army.mil | |
| Contact: Holly L McClung, M.S. 508-233-5309 holly.l.mcclung@us.army.mil | |
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
Combat Feeding Directorate, US Army Natick Soldier Research Development & Engineering Center
Investigators
| Principal Investigator: | Stefan M Pasiakos, Ph.D. | United States Army Research Institute of Environmental Medicine |
More Information
No publications provided
| Responsible Party: | United States Army Research Institute of Environmental Medicine |
| ClinicalTrials.gov Identifier: | NCT01714479 History of Changes |
| Other Study ID Numbers: | 12-18-HC |
| Study First Received: | October 23, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on June 17, 2013