Effect of Antioxidant on Endurance Performance in Healthy... | NCT00731926

Studies
Effect of Antioxidant on Endurance Performance in Healthy Men

NCT00731926

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 12, 2008Estimated

Enrollment

69Actual

Phase

Phase 2Phase 3

Conditions

Exercise Tolerance

Interventions

Oligomerized litchi fruit extract
VItamin C + Vitamin E mixture
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

May 20, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2008

Last Update Posted Date

Aug 12, 2008Estimated

Name	Class
University of California, Davis	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Dietary Supplement: Oligomerized litchi fruit extract
2	Active Comparator	Dietary Supplement: VItamin C + Vitamin E mixture
3	Placebo Comparator	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oligomerized litchi fruit extract	Dietary Supplement	100mg at once twice a day for 1 month	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
VO2max, anaerobic threshold		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang-chul Lee, professor	Institute of Complementary Alternative Medicine SNUMC	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C514283	oligonol
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

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