Effect of Antioxidant on Endurance Performance in Healthy Men

Exercise Tolerance Clinical Trial

Official title:

Effect of Antioxidant on Endurance Performance in Healthy Men -Double Blind Randomized Placebo and Active Controlled Trial-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731926
• Other study ID #: H-0707-028-212
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 20, 2008
• Last updated: August 10, 2008
• Start date: September 2007
• Est. completion date: February 2008

Study information

• Verified date: August 2008
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Tolerance

Intervention

Dietary Supplement:
• Oligomerized litchi fruit extract
100mg at once twice a day for 1 month
• VItamin C + Vitamin E mixture
Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month

Other:
• placebo
twice a day for 1 month

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of running time to exhaustion under 80% of maximal heart rate		1 month	No
Secondary	VO2max, anaerobic threshold		1 month	No