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Effect of Antioxidant on Endurance Performance in Healthy Men

NCT ID: NCT00731926

Last Updated: 2008-08-12

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-02-29

Brief Summary

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oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance

Detailed Description

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Regular physical exercise has many beneficial effects, but it has been reported that strenuous exercise could elevate the production of free radical and other reactive oxygen species (ROS) which eventually injure the tissues and decrease the muscle function.So many kinds of antioxidant supplementations have been tried to decrease the muscle fatigue and enhance the exercise performance. polyphenolic flavonoids abundant in fruits and leafy vegetables have strong antioxidant effect. oligomerized litchi fruit extract has strong antioxidant capacity and higher bioavailability compared to that of grape seed polyphenol. The aim of this study was to determine whether oligomerized litchi fruit extract could induce endurance exercise performance more than Vit C + Vit E mixture or placebo could do. Therefore, we designed double blind randomized controlled trial, setting the change of running time to exhaustion under submaximal treadmill test as the primary endpoint.

Conditions

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Exercise Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Oligomerized litchi fruit extract

Intervention Type DIETARY_SUPPLEMENT

100mg at once twice a day for 1 month

2

Group Type ACTIVE_COMPARATOR

VItamin C + Vitamin E mixture

Intervention Type DIETARY_SUPPLEMENT

Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

twice a day for 1 month

Interventions

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Oligomerized litchi fruit extract

100mg at once twice a day for 1 month

Intervention Type DIETARY_SUPPLEMENT

VItamin C + Vitamin E mixture

Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month

Intervention Type DIETARY_SUPPLEMENT

placebo

twice a day for 1 month

Intervention Type OTHER

Other Intervention Names

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oligonol; brand name of oligomerized litchi fruit extract

Eligibility Criteria

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Inclusion Criteria

* healthy men over 20 years old non-smoker

Exclusion Criteria

* BMI\>25 or body fat\>25% he who intakes the antioxidant supplement in recent 2 weeks
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Institute of Complementary Alternative Medicine

Principal Investigators

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Sang-chul Lee, professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Complementary Alternative Medicine SNUMC

Other Identifiers

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H-0707-028-212

Identifier Type: -

Identifier Source: org_study_id