Overview

This trial is active, not recruiting.

Condition healthy
Treatments placebo beverage, 2.8 g sustamine beverage, 19.6 g sustamine beverage
Sponsor University of Texas at Austin
Collaborator Kyowa Hakko Bio Co., Ltd.
Start date June 2012
End date October 2012
Trial size 14 participants
Trial identifier NCT01623947, 2012-03-0043

Summary

Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve cycling performance and mental acuity in a dose-dependent response.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Placebo Comparator)
placebo beverage
1400 ml flavored, colored, artificially sweetened, non-caloric beverage divided into 6 servings provided prior to and during the 2.5 hr interval ride.
(Active Comparator)
2.8 g sustamine beverage
1400 ml flavored, colored, artificially sweetened, beverage containing 2.8 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride.
(Active Comparator)
19.6 g sustamine beverage
1400 ml flavored, colored, artificially sweetened, beverage containing 19.6 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride.

Primary Outcomes

Measure
Improved Time Trial Performance
time frame: After 2.5 hr interval cycling

Secondary Outcomes

Measure
Improved Mental Function
time frame: After time trial

Eligibility Criteria

Male or female participants from 20 years up to 45 years old.

Inclusion Criteria: - Competitive cyclist or triathlete - Male (VO2max >= 55 ml/kg/min) or Female (VO2max >= 45 ml/kg/min) - Healthy - Blood pressure below 140/90 - Non-smoker Exclusion Criteria: - Anti-depressant medications - Inconsistent regular medications - Consumption performance-enhancing substances - Type I or Type II diabetes - Renal, hepatic or cardiac disease Current infectious disease

Additional Information

Official title Effects of Sustamine(TM) on Cycling Time Trial Performance Following Prolonged Cycling
Principal investigator John L. Ivy, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Texas at Austin.