- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01366924
Essential Amino Acids Supplementation and Muscle Protein Synthesis
July 19, 2017 updated by: United States Army Research Institute of Environmental Medicine
The Effect of Amino Acid Supplementation on Skeletal Muscle Protein Turnover Following Endurance Exercise
The modern warfighter faces numerous physiological challenges including sleep deprivation, sustained intense physical activity, and caloric restriction, the combined effects of which may result in the loss of lean body mass and decreased physical performance.
Dietary interventions may help preserve lean body mass and facilitate recovery from periods of intense physical demand.
For example, dietary strategies that increase amino acid availability have been shown to stimulate protein synthesis in skeletal muscle following resistance exercise.
Because military tasks also incorporate endurance exercise components, studies regarding the effects of increasing dietary amino acids following endurance exercise are warranted.
The objectives of this study are to characterize the effect of endurance exercise on protein synthesis and breakdown as well as the ability of an essential amino acid supplement to influence skeletal muscle protein metabolism and its cellular and molecular regulation following endurance exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
- Phase 1
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
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Boston, Massachusetts, United States, 02111
- Tufts University
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Natick, Massachusetts, United States, 01760
- US Army Research Institute of Environmental Medicine
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-
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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women aged 18 - 35 years
- Weight stable
- Recreationally active with VO2max of 40 - 50 ml/kg/min
- Refrain from taking any NSAIDS or any aspirin-containing medications
- Supervisor approval if a federal employee
Exclusion Criteria:
- Disease or medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
- Allergies to foods or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
- Abnormal PT/PTT test or problems with blood clotting
- Present condition of alcoholism or other substance abuse that compromises exercise capacity
- Musculoskeletal injuries that compromise the ability to exercise
- Pregnancy
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Muscle protein turnover and intracellular signaling at rest
Muscle protein turnover and intracellular signaling are measured at rest for comparison to post-exercise muscle metabolism.
|
|
Active Comparator: Muscle metabolism after endurance exercise
Post-exercise muscle protein metabolism was measured to determine if endurance exercise affects muscle metabolism compared to rest.
|
10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials
60 minute endurance exercise session
|
Experimental: Muscle Metabolism after endurance exercise
Muscle metabolism response to endurance exercise with essential amino acid supplementation
|
10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials
|
Experimental: Muscle anabolism after endurance exercise
Muscle anabolism after endurance exercise with essential amino acid supplementation.
|
10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in muscle protein synthesis after exercise or exercise with amino acid supplementation.
Time Frame: An average change over a 210 minute recovery period from a 60 minute endurance exercise session
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An average change over a 210 minute recovery period from a 60 minute endurance exercise session
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in intracellular signaling after exercise or exercise with amino acid supplementation.
Time Frame: At 30 minutes and 210 minutes after a 60 minute endurance exercise session
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At 30 minutes and 210 minutes after a 60 minute endurance exercise session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stefan M Pasiakos, Ph.D., US 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
- Pasiakos SM, McClung HL, McClung JP, Margolis LM, Andersen NE, Cloutier GJ, Pikosky MA, Rood JC, Fielding RA, Young AJ. Leucine-enriched essential amino acid supplementation during moderate steady state exercise enhances postexercise muscle protein synthesis. Am J Clin Nutr. 2011 Sep;94(3):809-18. doi: 10.3945/ajcn.111.017061. Epub 2011 Jul 20.
- Pasiakos SM, McClung HL, McClung JP, Urso ML, Pikosky MA, Cloutier GJ, Fielding RA, Young AJ. Molecular responses to moderate endurance exercise in skeletal muscle. Int J Sport Nutr Exerc Metab. 2010 Aug;20(4):282-90. doi: 10.1123/ijsnem.20.4.282.
- Scofield DE, McClung HL, McClung JP, Kraemer WJ, Rarick KR, Pierce JR, Cloutier GJ, Fielding RA, Matheny RW Jr, Young AJ, Nindl BC. A novel, noninvasive transdermal fluid sampling methodology: IGF-I measurement following exercise. Am J Physiol Regul Integr Comp Physiol. 2011 Jun;300(6):R1326-32. doi: 10.1152/ajpregu.00313.2010. Epub 2011 Mar 9.
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
May 1, 2007
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
June 1, 2011
First Submitted That Met QC Criteria
June 2, 2011
First Posted (Estimate)
June 6, 2011
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- H06-04
- 7906 Tufts
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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