NCT01366924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
Last Updated

July 21, 2017

Status Verified

June 1, 2011

Enrollment Period

3.2 years

First QC Date

June 1, 2011

Last Update Submit

July 19, 2017

Conditions

Keywords

protein turnoverwhole body protein turnoveressential amino acidsleucine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (4)

Muscle protein turnover and intracellular signaling at rest

NO INTERVENTION

Muscle protein turnover and intracellular signaling are measured at rest for comparison to post-exercise muscle metabolism.

Muscle metabolism after endurance exercise

ACTIVE COMPARATOR

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

Dietary Supplement: Essential Amino AcidsOther: Endurance exercise

Muscle Metabolism after endurance exercise

EXPERIMENTAL

Muscle metabolism response to endurance exercise with essential amino acid supplementation

Dietary Supplement: Essential Amino Acids

Muscle anabolism after endurance exercise

EXPERIMENTAL

Muscle anabolism after endurance exercise with essential amino acid supplementation.

Dietary Supplement: Essential Amino Acids

Interventions

Essential Amino AcidsDIETARY_SUPPLEMENT

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

Muscle Metabolism after endurance exerciseMuscle anabolism after endurance exerciseMuscle metabolism after endurance exercise

60 minute endurance exercise session

Muscle metabolism after endurance exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts University

Boston, Massachusetts, 02111, United States

Location

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Related 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.

    PMID: 21775557BACKGROUND
  • 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.

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Amino Acids, Essential

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Stefan M Pasiakos, Ph.D.

    US Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 6, 2011

Study Start

May 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 21, 2017

Record last verified: 2011-06

Locations