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CompletedNCT01366924Updated Jul 21, 2017

Essential Amino Acids Supplementation and Muscle Protein Synthesis

A Phase 1/2 interventional study of Essential Amino Acids and Endurance exercise in Muscle Loss and Muscle Anabolism, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 2 sites in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by United States Army Research Institute of Environmental Medicine · Phase 1/2, Interventional, and Basic science

Phase
Phase 1/2
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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.

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Conditions studied

  • Muscle Loss
  • Muscle Anabolism

Keywords

  • protein turnover
  • whole body protein turnover
  • essential amino acids
  • leucine
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In context

Lead sponsor

United States Army Research Institute of Environmental Medicine is the lead sponsor of 67 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • 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.

    Dietary Supplement: Essential Amino Acids · Other: Endurance exercise

  • Experimental
    Muscle Metabolism after endurance exercise

    Muscle metabolism response to endurance exercise with essential amino acid supplementation

    Dietary Supplement: Essential Amino Acids

  • Experimental
    Muscle anabolism after endurance exercise

    Muscle anabolism after endurance exercise with essential amino acid supplementation.

    Dietary Supplement: Essential Amino Acids

Interventions

  • Dietary supplementEssential Amino Acids

    10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials

  • OtherEndurance exercise

    60 minute endurance exercise session

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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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Study locations

2 sites
  • Tufts University
    Boston, Massachusetts 02111, United States
  • US Army Research Institute of Environmental Medicine
    Natick, Massachusetts 01760, United States
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References and documents

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. PubMed 21775557 ↗
  • 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. PubMed 20739716 ↗
  • 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. PubMed 21389329 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01366924
Lead sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
Tufts University
First posted
Jun 6, 2011
Start date
May 2007
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Jul 21, 2017

Study contacts

Stefan M Pasiakos, Ph.D.
principal investigator · US Army Research Institute of Environmental Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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