Essential Amino Acids Supplementation and Muscle Protein Synthesis

NCT ID: NCT01366924

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Loss Muscle Anabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Muscle metabolism after endurance exercise

Post-exercise muscle protein metabolism was measured to determine if endurance exercise affects muscle metabolism compared to rest.

Group Type ACTIVE_COMPARATOR

Essential Amino Acids

Intervention Type DIETARY_SUPPLEMENT

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

Endurance exercise

Intervention Type OTHER

60 minute endurance exercise session

Muscle Metabolism after endurance exercise

Muscle metabolism response to endurance exercise with essential amino acid supplementation

Group Type EXPERIMENTAL

Essential Amino Acids

Intervention Type DIETARY_SUPPLEMENT

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

Muscle anabolism after endurance exercise

Muscle anabolism after endurance exercise with essential amino acid supplementation.

Group Type EXPERIMENTAL

Essential Amino Acids

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Essential Amino Acids

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

Intervention Type DIETARY_SUPPLEMENT

Endurance exercise

60 minute endurance exercise session

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tufts University

OTHER

Sponsor Role collaborator

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

United States Army Research Institute of Environmental Medicine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan M Pasiakos, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

US Army Research Institute of Environmental Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tufts University

Boston, Massachusetts, United States

Site Status

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21775557 (View on PubMed)

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.

Reference Type RESULT
PMID: 20739716 (View on PubMed)

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.

Reference Type RESULT
PMID: 21389329 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7906 Tufts

Identifier Type: -

Identifier Source: secondary_id

H06-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.