Effects of Sustamine(TM) on Cycling Time Trial Performance

NCT ID: NCT01623947

Last Updated: 2013-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo Beverage

Intervention Type DIETARY_SUPPLEMENT

1400 ml flavored, colored, artificially sweetened, non-caloric beverage divided into 6 servings provided prior to and during the 2.5 hr interval ride.

2.8 g Sustamine

Group Type ACTIVE_COMPARATOR

2.8 g Sustamine Beverage

Intervention Type DIETARY_SUPPLEMENT

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.

19.6 g Sustamine

Group Type ACTIVE_COMPARATOR

19.6 g Sustamine Beverage

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kyowa Hakko Bio Co., Ltd.

INDUSTRY

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John L. Ivy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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The University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2012-03-0043

Identifier Type: -

Identifier Source: org_study_id

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