Effect of Antioxidant on Endurance Performance in Healthy Men

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

oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance

Study Overview

• Status: Completed
• Conditions: Exercise Tolerance
• Intervention / Treatment: Dietary supplement: Oligomerized litchi fruit extract; Dietary supplement: VItamin C + Vitamin E mixture; Other: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Dietary supplement: Oligomerized litchi fruit extract; 100mg at once twice a day for 1 month; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of running time to exhaustion under 80% of maximal heart rate	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
VO2max, anaerobic threshold	1 month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: University of California, Davis
• Investigators: Principal Investigator: Sang-chul Lee, professor, Institute of Complementary Alternative Medicine SNUMC

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: May 20, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 11, 2008

Study Record Updates

• Last Update Posted (Estimate): August 12, 2008
• Last Update Submitted That Met QC Criteria: August 10, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Vitamins; Ascorbic Acid
• Other Study ID Numbers: H-0707-028-212