NCT00731926

Brief Summary

oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
Last Updated

August 12, 2008

Status Verified

August 1, 2008

Enrollment Period

4 months

First QC Date

May 20, 2008

Last Update Submit

August 10, 2008

Conditions

Exercise Tolerance

Outcome Measures

Primary Outcomes (1)

  • change of running time to exhaustion under 80% of maximal heart rate

    1 month

Secondary Outcomes (1)

  • VO2max, anaerobic threshold

    1 month

Study Arms (3)

1

EXPERIMENTAL
Dietary Supplement: Oligomerized litchi fruit extract

2

ACTIVE COMPARATOR
Dietary Supplement: VItamin C + Vitamin E mixture

3

PLACEBO COMPARATOR
Other: placebo

Interventions

Oligomerized litchi fruit extractDIETARY_SUPPLEMENT

100mg at once twice a day for 1 month

Also known as: oligonol; brand name of oligomerized litchi fruit extract
1
VItamin C + Vitamin E mixtureDIETARY_SUPPLEMENT

Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month

2
placeboOTHER

twice a day for 1 month

3

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men over 20 years old non-smoker

You may not qualify if:

  • BMI\>25 or body fat\>25% he who intakes the antioxidant supplement in recent 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

oligonolAscorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Sang-chul Lee, professor

    Institute of Complementary Alternative Medicine SNUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2008

First Posted

August 11, 2008

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

August 12, 2008

Record last verified: 2008-08