Effects of Sustamine(TM) on Cycling Time Trial Performance

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo Beverage; Dietary supplement: 2.8 g Sustamine Beverage; Dietary supplement: 19.6 g Sustamine Beverage

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • The University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Mental Function	Mental function will be assessed using a computer-based Stroop Test. Measurements will be collected before treatment, before exercise and after exercise.	After time trial

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Kyowa Hakko Bio Co., Ltd.
• Investigators: Principal Investigator: John L. Ivy, Ph.D., University of Texas at Austin

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: glutamine; cycling performance; mental function
• Other Study ID Numbers: 2012-03-0043