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| Sponsors and Collaborators: |
Seoul National University Hospital University of California, Davis |
| Information provided by: | Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00731926 |
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 II Phase III |
| MedlinePlus related topics: | Antioxidants Dietary Supplements Exercise and Physical Fitness |
| Drug Information available for: | Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Ascorbic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Antioxidant on Endurance Performance in Healthy Men -Double Blind Randomized Placebo and Active Controlled Trial- |
| 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 |
| 1: Experimental |
Dietary Supplement: Oligomerized litchi fruit extract
100mg at once twice a day for 1 month
|
| 2: Active Comparator |
Dietary Supplement: VItamin C + Vitamin E mixture
Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month
|
| 3: Placebo Comparator |
Other: placebo
twice a day for 1 month
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Institute of Complementary Alternative Medicine ( Sang-chul Lee MD., Ph.D / chief director ) |
| Study ID Numbers: | H-0707-028-212 |
| First Received: | May 20, 2008 |
| Last Updated: | August 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00731926 |
| Health Authority: | Korea: Food and Drug Administration |
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