NCT01714479

Brief Summary

Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. The typical assault load is approximately 25 kg, although loads as high as 55 kg are often carried, which when combined with extreme energy expenditures can degrade health and performance, and increase the risk of injury. Branched-chain amino acid (leucine) supplementation may confer protection against the negative effects of operational stress by stimulating muscle protein synthesis and reducing degradation. This study will determine if leucine-enriched nutrition supplementation confers protection against the negative consequences of sustained load carriage exercise, and explore the mechanisms by which leucine might impart protection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 21, 2017

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

October 23, 2012

Last Update Submit

July 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in muscle protein synthesis and whole-body protein turnover during and after load carriage or conventional exercise with or without amino acid supplementation

    90 min exercise bout (exercise) and 180 min of recovery

Secondary Outcomes (1)

  • Changes in muscle performance in recovery from load carriage or conventional exercise with or without amino acid supplementation

    4, 24, 48, and 72 hours post exercise

Study Arms (4)

Load Carriage - Control

PLACEBO COMPARATOR

Load Carriage - with a calorie-free placebo

Other: Placebo

Load Carriage - leucine-enriched nutrition supplement

EXPERIMENTAL

Load Carriage with leucine-enriched amino acid supplementation

Other: Leucine-enriched nutritional supplement

Conventional Exercise - Control

PLACEBO COMPARATOR

Conventional Exercise with a calorie-free placebo

Other: Placebo

Conventional Exercise - Leucine-enriched Nutrition Supplement

ACTIVE COMPARATOR

Conventional Exercise with leucine-enriched Amino Acid supplementation

Other: Leucine-enriched nutritional supplement

Interventions

A protein and carbohydrate supplement with high levels of leucine

Conventional Exercise - Leucine-enriched Nutrition SupplementLoad Carriage - leucine-enriched nutrition supplement
PlaceboOTHER
Conventional Exercise - ControlLoad Carriage - Control

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 - 60 ml/kg/min
  • Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®), or any aspirin-containing products, alchohol, and nicotine
  • Females must be on oral contraception

You may not qualify if:

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders
  • Disease or medication that affects macronutrient metabolism or the ability to participate in strenuous exercise
  • Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be used in the study
  • Anemia (HCT \<38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with blood clotting
  • Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
  • Musculoskeletal injuries that compromise the ability to exercise
  • Blood donation within 8 weeks of enrollment
  • Pregnancy and women not on oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Related Publications (3)

  • Margolis LM, McClung HL, Murphy NE, Carrigan CT, Pasiakos SM. Skeletal Muscle myomiR Are Differentially Expressed by Endurance Exercise Mode and Combined Essential Amino Acid and Carbohydrate Supplementation. Front Physiol. 2017 Mar 23;8:182. doi: 10.3389/fphys.2017.00182. eCollection 2017.

    PMID: 28386239BACKGROUND
  • Pasiakos SM, McClung HL, Margolis LM, Murphy NE, Lin GG, Hydren JR, Young AJ. Human Muscle Protein Synthetic Responses during Weight-Bearing and Non-Weight-Bearing Exercise: A Comparative Study of Exercise Modes and Recovery Nutrition. PLoS One. 2015 Oct 16;10(10):e0140863. doi: 10.1371/journal.pone.0140863. eCollection 2015.

  • Margolis LM, Murphy NE, Carrigan CT, McClung HL, Pasiakos SM. Ingesting a Combined Carbohydrate and Essential Amino Acid Supplement Compared to a Non-Nutritive Placebo Blunts Mitochondrial Biogenesis-Related Gene Expression after Aerobic Exercise. Curr Dev Nutr. 2017 May 23;1(6):e000893. doi: 10.3945/cdn.117.000893. eCollection 2017 Jun.

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stefan M Pasiakos, Ph.D.

    United States Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 26, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 21, 2017

Record last verified: 2016-09

Locations