Effects of Sustamine(TM) on Cycling Time Trial Performance

Sponsor

University of Texas at Austin (Other)

Overall Status

Unknown status

CT.gov ID

NCT01623947

Collaborator

Kyowa Hakko Bio Co., Ltd. (Industry)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Placebo Beverage Dietary Supplement: 2.8 g Sustamine Beverage Dietary Supplement: 19.6 g Sustamine Beverage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Effects of Sustamine(TM) on Cycling Time Trial Performance Following Prolonged Cycling

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Dietary Supplement: 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	Dietary Supplement: 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	Dietary Supplement: 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.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Dietary Supplement: 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

Dietary Supplement: 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

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

Improved Time Trial Performance [After 2.5 hr interval cycling]
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.

Secondary Outcome Measures

Improved Mental Function [After time trial]
Mental function will be assessed using a computer-based Stroop Test. Measurements will be collected before treatment, before exercise and after exercise.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas at Austin	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin
Kyowa Hakko Bio Co., Ltd.

Investigators

Principal Investigator: John L. Ivy, Ph.D., University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT01623947

Other Study ID Numbers:

2012-03-0043

First Posted:

Jun 20, 2012

Last Update Posted:

Apr 19, 2013

Last Verified:

Apr 1, 2013

Keywords provided by University of Texas at Austin

glutamine

cycling performance

mental function

Study Results

No Results Posted as of Apr 19, 2013