HealthyNCT01113827
Effects of Water-soluble Olive Extract Supplementation
A study testing Olive Extract in people with Healthy, run by University of Texas at Austin at 1 site in United States.
Trial summary
Six weeks of supplementation of an olive extract will: Improve antioxidant status Reduce inflammation Reduce muscle damage Improve exercise performance Improve exercise recovery as compared to a placebo. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olive Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2012
- Phase
- Interventional
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreational exerciser
- BMI <= 30
- Non-smoker
Who cannot join
- Blood pressure over 140/90
- Type I or Type II diabetes
- Renal, hepatic or cardiac disease
- Current infectious disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Effects of Water-soluble Olive Extract on Antioxidant Status, Exercise Performance, Muscle Metabolism, Muscle Damage and Inflammation
Six weeks of supplementation of an olive extract will:
- Improve antioxidant status
- Reduce inflammation
- Reduce muscle damage
- Improve exercise performance
- Improve exercise recovery as compared to a placebo.
- Conditions
- Healthy
- Being tested
- Olive Extract, Placebo
- Keywords
- Olive, antioxidant, exercise, inflammation, recovery, Healthy men
- Medical subject headings
- Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive ExtractDietary supplement
Capsule form ingested 1x/day for 6 weeks
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 150mg olive extract | Active comparator | Not described Receives: Dietary Supplement: Olive Extract |
| 50mg olive extract | Active comparator | Not described Receives: Dietary Supplement: Olive Extract |
| Placebo control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Antioxidant Status
Measured: 6 weeks
Secondary outcomes (1)
Reduced Inflammation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- John Ivy, Ph.D., Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113827
- Sponsor's protocol ID
- 2009-09-01-OLIV
- Status last verified
- Feb 2012
- First submitted
- 28 Apr 2010
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Water-soluble Olive Extract on Antioxidant Status, Exercise Performance, Muscle Metabolism, Muscle Damage and Inflammation
- ClinicalTrials.gov ID
- NCT01113827
- Acronym / sponsor ID
- 2009-09-01-OLIV
- Conditions
- Healthy
- Keywords
- Olive, antioxidant, exercise, inflammation, recovery, Healthy men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Apr 2010 (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.
Six weeks of supplementation of an olive extract will:
- Improve antioxidant status
- Reduce inflammation
- Reduce muscle damage
- Improve exercise performance
- Improve exercise recovery as compared to a placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150mg olive extract | Active comparator | Dietary Supplement: Olive Extract |
| 50mg olive extract | Active comparator | Dietary Supplement: Olive Extract |
| Placebo control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recreational exerciser
- BMI <= 30
- Non-smoker
Key exclusion criteria (4 listed)
- Blood pressure over 140/90
- Type I or Type II diabetes
- Renal, hepatic or cardiac disease
- Current infectious disease
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 |
|---|---|---|
| Olive ExtractCapsule form ingested 1x/day for 6 weeks | Dietary supplement | 150mg olive extract, 50mg olive extract |
| PlaceboPlacebo | Dietary supplement | Placebo control |
Primary outcome
Improved Antioxidant Status
Time frame: 6 weeks
1 secondary outcome
Reduced Inflammation
Time frame: 6 weeks
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 27 Mar 2012.
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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.
John Ivy, Ph.D. principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Extract in people with Healthy, run by University of Texas at Austin at 1 site in United States.
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 3 inclusion and 4 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 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Improved Antioxidant Status (time frame: 6 weeks). 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 27 Mar 2012.