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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01781910
Other study ID # CHRMS M12-101
Secondary ID
Status Completed
Phase N/A
First received January 30, 2013
Last updated January 31, 2013
Start date September 2011

Study information

Verified date January 2013
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Supplementation with branched chain amino acids (BCAAs) has been used to stimulate muscle protein synthesis following exercise. The purpose of this study was to determine if supplementation with BCAAs in combination with glucose would reduce exercise-induced delayed onset muscle soreness (DOMS). Using a double-blind crossover design, 20 subjects (11 females, 9 males) were randomly assigned to either BCAA (n=10) or placebo (n=10) groups. Subjects performed a squatting exercise to elicit DOMS and rated their muscle soreness every 24 hours for four days following exercise while continuing to consume the BCAA or placebo. Following a three-week recovery period, subjects returned and received the alternate BCAA or placebo treatment, repeating the same exercise and DOMS rating protocol for the next four days. BCAA supplementation in female subjects resulted in a significant decrease in DOMS versus placebo at 24 hours following exercise (p = 0.018). No significant effect of BCAA supplementation versus placebo was noted in male subjects, nor when male and female results were analyzed together. This gender difference may be related to dose per body weight differences between male and female subjects.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Exercise-induced Delayed Onset Muscle Soreness
  • Myalgia

Intervention

Dietary Supplement:
Branched Chain Amino Acid drink supplement

Placebo


Locations

Country Name City State
United States University of Vermont Burlington Vermont

Sponsors (1)

Lead Sponsor Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Delayed Onset Muscle Soreness Rating Scale Every 24 hours for four days following exercise No