NCT01781910

Brief Summary

The purpose of this study is to determine if a dietary supplement containing branched chain amino acids will reduce the muscle soreness that sometimes occurs in the days following exercise.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

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

September 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

January 30, 2013

Last Update Submit

January 31, 2013

Conditions

Exercise-induced Delayed Onset Muscle Soreness

Keywords

branched chain amino acids, exercise, delayed onset muscle soreness

Outcome Measures

Primary Outcomes (1)

  • Delayed Onset Muscle Soreness Rating Scale

    Every 24 hours for four days following exercise

Study Arms (2)

Branch Chain Amino Acid supplement

EXPERIMENTAL

A drink supplement containing 1.22 grams of branched chain amino acids, plus glucose.

Dietary Supplement: Branched Chain Amino Acid drink supplement

Placebo supplement

PLACEBO COMPARATOR

The placebo was formulated to match both the taste and color of the test supplement. Crystal Light Lemonade powder (Kraft Foods, Northfield, IL, USA) was mixed with 5.6g of powdered dextrose (Now Foods, Bloomingdale, IL, USA) to match the amount of dextrose present in the BCAA supplement.

Dietary Supplement: Placebo

Interventions

Branched Chain Amino Acid drink supplementDIETARY_SUPPLEMENT
Branch Chain Amino Acid supplement
PlaceboDIETARY_SUPPLEMENT
Placebo supplement

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men (n=9) and women (n=11) aged 18-25 who engaged in no more than one hour of light to moderate intensity physical activity per week were recruited from the Greater Burlington, Vermont area.

You may not qualify if:

  • individuals who engaged in more than one hour per week of light to moderate physical activity
  • had been involved in strict athletic competition or weight training in the past six months
  • were pregnant or nursing, had a known muscular disease, diabetes mellitus, cardiovascular disease, respiratory disease, and/or were currently taking a protein-based dietary supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stephen J Pintauro, Ph.D.

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 1, 2013

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

US(1)