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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01366924
Other study ID # H06-04
Secondary ID 7906 Tufts
Status Completed
Phase Phase 1/Phase 2
First received June 1, 2011
Last updated July 19, 2017
Start date May 2007
Est. completion date July 2010

Study information

Verified date June 2011
Source United States Army Research Institute of Environmental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Essential Amino Acids
10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials
Other:
Endurance exercise
60 minute endurance exercise session

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
United States Army Research Institute of Environmental Medicine Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 Integ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in muscle protein synthesis after exercise or exercise with amino acid supplementation. An average change over a 210 minute recovery period from a 60 minute endurance exercise session
Secondary Change in intracellular signaling after exercise or exercise with amino acid supplementation. At 30 minutes and 210 minutes after a 60 minute endurance exercise session
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