Effects of Sustamine(TM) on Cycling Time Trial Performance
1 other identifier
interventional
14
1 country
1
Brief Summary
Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve cycling performance and mental acuity in a dose-dependent response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedApril 19, 2013
April 1, 2013
4 months
June 18, 2012
April 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improved Time Trial Performance
Participants will perform an interval ride on a cycling ergometer for 2.5 hr. Intervals will be at 50% or 75% of the participant's VO2max. The time trial will consist of 4 km up a constant grade.
After 2.5 hr interval cycling
Secondary Outcomes (1)
Improved Mental Function
After time trial
Study Arms (3)
Placebo
PLACEBO COMPARATOR2.8 g Sustamine
ACTIVE COMPARATOR19.6 g Sustamine
ACTIVE COMPARATORInterventions
1400 ml flavored, colored, artificially sweetened, non-caloric beverage divided into 6 servings provided prior to and during the 2.5 hr interval ride.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Anti-depressant medications
- Inconsistent regular medications
- Consumption performance-enhancing substances
- Type I or Type II diabetes
- Renal, hepatic or cardiac disease Current infectious disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas at Austinlead
- Kyowa Hakko Bio Co., Ltd.collaborator
Study Sites (1)
The University of Texas at Austin
Austin, Texas, 78712, United States
Study Officials
- PRINCIPAL INVESTIGATOR
John L. Ivy, Ph.D.
University of Texas at Austin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2012
First Posted
June 20, 2012
Study Start
June 1, 2012
Primary Completion
October 1, 2012
Study Completion
May 1, 2013
Last Updated
April 19, 2013
Record last verified: 2013-04