Effect of Antioxidant on Endurance Performance in Healthy Men

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00731926
First received: May 20, 2008
Last updated: August 10, 2008
Last verified: August 2008
  Purpose

oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance


Condition Intervention Phase
Exercise Tolerance
Dietary Supplement: Oligomerized litchi fruit extract
Dietary Supplement: VItamin C + Vitamin E mixture
Other: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Antioxidant on Endurance Performance in Healthy Men -Double Blind Randomized Placebo and Active Controlled Trial-

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change of running time to exhaustion under 80% of maximal heart rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VO2max, anaerobic threshold [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Oligomerized litchi fruit extract
100mg at once twice a day for 1 month
Other Name: oligonol; brand name of oligomerized litchi fruit extract
Active Comparator: 2 Dietary Supplement: VItamin C + Vitamin E mixture
Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month
Placebo Comparator: 3 Other: placebo
twice a day for 1 month

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00731926

Sponsors and Collaborators
Seoul National University Hospital
University of California, Davis
Investigators
Principal Investigator: Sang-chul Lee, professor Institute of Complementary Alternative Medicine SNUMC
  More Information

No publications provided

Responsible Party: Sang-chul Lee MD., Ph.D / chief director, Institute of Complementary Alternative Medicine
ClinicalTrials.gov Identifier: NCT00731926     History of Changes
Other Study ID Numbers: H-0707-028-212
Study First Received: May 20, 2008
Last Updated: August 10, 2008
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Antioxidants
Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 01, 2014