Exercise TolerancePhase 2/3NCT00731926
Effect of Antioxidant on Endurance Performance in Healthy Men
A Phase 2/3 study testing Oligomerized litchi fruit extract and VItamin C + Vitamin E mixture in people with Exercise Tolerance, run by Seoul National University Hospital.
Trial summary
oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Tolerance
- What is being tested?
- Oligomerized litchi fruit extract and VItamin C + Vitamin E mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Feb 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men over 20 years old non-smoker
Who cannot join
- BMI>25 or body fat>25% he who intakes the antioxidant supplement in recent 2 weeks
About this study
Official title: 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
Read the 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.
- Conditions
- Exercise Tolerance
- Being tested
- Oligomerized litchi fruit extract, VItamin C + Vitamin E mixture, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligomerized litchi fruit extractDietary supplement
Also called oligonol; brand name of oligomerized litchi fruit extract
100mg at once twice a day for 1 month
VItamin C + Vitamin E mixtureDietary supplement
Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month
placeboOther
twice a day for 1 month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Oligomerized litchi fruit extract |
| 2 | Active comparator | Not described Receives: Dietary Supplement: VItamin C + Vitamin E mixture |
| 3 | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of running time to exhaustion under 80% of maximal heart rate
Measured: 1 month
Secondary outcomes (1)
VO2max, anaerobic threshold
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise ToleranceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Investigators
- Sang-chul Lee, professor, Principal investigator, Institute of Complementary Alternative Medicine SNUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731926
- Sponsor's protocol ID
- H-0707-028-212
- Status last verified
- Aug 2008
- First submitted
- 20 May 2008
- Last updated
- 12 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antioxidant on Endurance Performance in Healthy Men -Double Blind Randomized Placebo and Active Controlled Trial-
- ClinicalTrials.gov ID
- NCT00731926
- Acronym / sponsor ID
- H-0707-028-212
- Conditions
- Exercise Tolerance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Sep 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Oligomerized litchi fruit extract |
| 2 | Active comparator | Dietary Supplement: VItamin C + Vitamin E mixture |
| 3 | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men over 20 years old non-smoker
Key exclusion criteria (1 listed)
- BMI>25 or body fat>25% he who intakes the antioxidant supplement in recent 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligomerized litchi fruit extractAlso: oligonol; brand name of oligomerized litchi fruit extract100mg at once twice a day for 1 month | Dietary supplement | 1 |
| VItamin C + Vitamin E mixtureVitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month | Dietary supplement | 2 |
| placebotwice a day for 1 month | Other | 3 |
Primary outcome
change of running time to exhaustion under 80% of maximal heart rate
Time frame: 1 month
1 secondary outcome
VO2max, anaerobic threshold
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-chul Lee, professor principal investigator
Institute of Complementary Alternative Medicine SNUMC
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oligomerized litchi fruit extract and VItamin C + Vitamin E mixture in people with Exercise Tolerance, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of running time to exhaustion under 80% of maximal heart rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2008.