Sedentary LifestylePhase 2NCT01615445
Resveratrol Supplementation on Exercise in Healthy Sedentary Adults
A Phase 2 study testing Resveratrol in people with Sedentary Lifestyle, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Previous animal studies have found that resveratrol supplementation significantly increased aerobic capacity. The investigators conducted a randomized placebo-controlled cross-over study to assess whether resveratrol could provide similar benefits in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Aug 2011
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between the age of 18-65 years
- healthy, sedentary as per CDC (Less than 150 minutes of moderate activity[brisk walking] or less than 75 minutes of strenuous activity [jogging] on a typical week)
- not planning a significant change in their level of physical activity during the study period
- have a body mass index (BMI) between 20 and 30
- give informed consent and be willing to comply with protocol requirements
Who cannot join
- have heart disease, lung disease, and liver disease
- be unable to perform maximal exercise on a cycle ergometer ("maximal" defined by attainment of peak heart rate or ventilation within 15% of the predicted maximum or a respiratory quotient of > 1.15). It should be noted that maximal does not imply normal aerobic capacity
- use medications that may affect exercise performance ( β-blockers, Ca channel blockers
- be a smoker or have a past history of smoking more than total 5 pkg/year
- be pregnant or lactating
- use oral contraceptives
Show all 34Show fewer
- have severe or unstable medical illness
- have blood/urine screening test results outside of the normal reference range and deemed clinically significant by the clinical investigator. Note: only minor variations in screening results outside of the normal references ranges will be permitted.
- take an anticoagulant, antiplatelet, NSAID, antidiabetic, antihypertensive, estrogen, SERM, immunosuppressant, vasodilator drug; or a significant medication metabolized via cytochrome P450 enzymes
- have current or history of a hormonal disorder, including cancer
- have a bleeding disorder, autoimmune condition
- have allergies to any of the ingredients in the study product or placebo
- have thrombosis of lower extremities
- have electrolyte abnormalities
- have recent myocardial infarction (i.e. within one year or less)
- have unstable angina
- have uncontrolled arrhythmia's causing symptoms or haemodynamic compromise
- have active endocarditis
- have acute myocarditis or pericarditis
- have symptomatic severe aortic stenosis
- have uncontrolled heart failure
- have acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
- have a left main coronary stenosis or its equivalent
- have moderate stenotic valvular heart disease
- have severe untreated arterial hypertension (>200 mmHg systolic, >120 mmHg diastolic)
- have significant pulmonary hypertension
- have tachyarrhythmias or bradyarrhythmias
- have hypertrophic cardiomyopathy
- have mental impairment leading to inability to cooperate
- have high-degree atrioventricular block
- have cardiac (bradyarrhythmias, ventricular tachycardia, myocardial infarction, heart failure, hypotension, and shock) and non-cardiac (musculoskeletal trauma, severe fatigue, dizziness, fainting, body aches) complications.
- have kidney disease
- have excessive vomiting
- be dehydrated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Clinical Trial of Resveratrol Supplementation on Exercise in Healthy Sedentary Adults
Previous animal studies have found that resveratrol supplementation significantly increased aerobic capacity. The investigators conducted a randomized placebo-controlled cross-over study to assess whether resveratrol could provide similar benefits in humans.
All participants were assigned to two 4-week treatment periods, with a 2 week washout in-between. During one period, volunteers in received resveratrol and during the other period, they received identical-appearing placebo.
The primary outcome of interest was change in exercise capacity, as measured by change in exercise duration on constant load exercise testing and change in aerobic capacity (peak VO2) on incremental exercise testing. Secondary outcomes were tolerability and side-effects associated with resveratrol.
- Conditions
- Sedentary Lifestyle
- Being tested
- Resveratrol, placebo
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Group A: resveratrol 1000 mg (500 mg twice) daily for 1 week then by tolerance and safety 2000 mg (1 000mg twice) daily for 3 weeks, followed by no medication for two weeks and then placebo for twice daily for 4 weeks.
placeboDrug
Participants will receive placebo daily for 4 weeks, followed by no medication for two weeks and then resveratrol 1 000 mg(500 mg twice) daily for 1 week, then by tolerance and safety 2 000 mg (1 000 mg twice) daily for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Active comparator | Group A Participants will received resveratrol 500 mg twice daily for 1 week then 1000 mg twice daily for 3 weeks, according to tolerance. They will discontinue medication for 2 weeks. The will receive placebo for 4 weeks. Receives: Drug: Resveratrol |
| Placebo | Placebo comparator | Group B (n=6) Will receive placebo for 4 weeks, they will discontinue medication for two weeks. Then receive resveratrol for 4 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in duration of constant load exercise
The primary outcome would be the change in constant load exercise duration between baseline and follow-up visits, expressed as a percent change from the baseline constant load test. The average change from baseline will be compared between the experimental and control groups.
Measured: Phase I: Baseline and 4 weeks; Phase II (cross-over phase): 6 weeks and 10 weeks
Change from baseline in aerobic capacity(peak VO2)
The aerobic capacity (peak VO2)is assessed by incremental exercise tests.
Measured: Phase I: Baseline and 4 weeks; Phase II (cross-over phase): 6 weeks and 10 weeks
Secondary outcomes (1)
Number of participants with Adverse Events
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startFeb 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nha Voduc, MD, Principal investigator, The Ottawa Hospital, The Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615445
- Sponsor's protocol ID
- 2008540-01H
- Status last verified
- Jun 2014
- First submitted
- 25 May 2012
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Voduc N, la Porte C, Tessier C, Mallick R, Cameron DW. Effect of resveratrol on exercise capacity: a randomized placebo-controlled crossover pilot study. Appl Physiol Nutr Metab. 2014 Oct;39(10):1183-7. doi: 10.1139/apnm-2013-0547. Epub 2014 Apr 30.
PubMed 25051174
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Clinical Trial of Resveratrol Supplementation on Exercise in Healthy Sedentary Adults
- ClinicalTrials.gov ID
- NCT01615445
- Acronym / sponsor ID
- 2008540-01H
- Conditions
- Sedentary Lifestyle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jun 2012 (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.
Previous animal studies have found that resveratrol supplementation significantly increased aerobic capacity. The investigators conducted a randomized placebo-controlled cross-over study to assess whether resveratrol could provide similar benefits in humans.
All participants were assigned to two 4-week treatment periods, with a 2 week washout in-between. During one period, volunteers in received resveratrol and during the other period, they received identical-appearing placebo.
The primary outcome of interest was change in exercise capacity, as measured by change in exercise duration on constant load exercise testing and change in aerobic capacity (peak VO2) on incremental exercise testing. Secondary outcomes were tolerability and side-effects associated with resveratrol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Active comparator | Drug: ResveratrolGroup A Participants will received resveratrol 500 mg twice daily for 1 week then 1000 mg twice daily for 3 weeks, according to tolerance. They will discontinue medication for 2 weeks. The will receive placebo for 4 weeks. |
| Placebo | Placebo comparator | Drug: placeboGroup B (n=6) Will receive placebo for 4 weeks, they will discontinue medication for two weeks. Then receive resveratrol for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between the age of 18-65 years
- healthy, sedentary as per CDC (Less than 150 minutes of moderate activity[brisk walking] or less than 75 minutes of strenuous activity [jogging] on a typical week)
- not planning a significant change in their level of physical activity during the study period
- have a body mass index (BMI) between 20 and 30
- give informed consent and be willing to comply with protocol requirements
Key exclusion criteria (34 listed)
- have heart disease, lung disease, and liver disease
- be unable to perform maximal exercise on a cycle ergometer ("maximal" defined by attainment of peak heart rate or ventilation within 15% of the predicted maximum or a respiratory quotient of > 1.15). It should be noted that maximal does not imply normal aerobic capacity
- use medications that may affect exercise performance ( β-blockers, Ca channel blockers
- be a smoker or have a past history of smoking more than total 5 pkg/year
- be pregnant or lactating
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 |
|---|---|---|
| ResveratrolGroup A: resveratrol 1000 mg (500 mg twice) daily for 1 week then by tolerance and safety 2000 mg (1 000mg twice) daily for 3 weeks, followed by no medication for two weeks and then placebo for twice daily for 4 weeks. | Drug | Resveratrol |
| placeboParticipants will receive placebo daily for 4 weeks, followed by no medication for two weeks and then resveratrol 1 000 mg(500 mg twice) daily for 1 week, then by tolerance and safety 2 000 mg (1 000 mg twice) daily for three weeks. | Drug | Placebo |
Primary outcome
Change from baseline in duration of constant load exercise
Time frame: Phase I: Baseline and 4 weeks; Phase II (cross-over phase): 6 weeks and 10 weeks
The primary outcome would be the change in constant load exercise duration between baseline and follow-up visits, expressed as a percent change from the baseline constant load test. The average change from baseline will be compared between the experimental and control groups.
Change from baseline in aerobic capacity(peak VO2)
Time frame: Phase I: Baseline and 4 weeks; Phase II (cross-over phase): 6 weeks and 10 weeks
The aerobic capacity (peak VO2)is assessed by incremental exercise tests.
1 secondary outcome
Number of participants with Adverse Events
Time frame: up to 10 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 23 Jun 2014.
- Results publication: PubMed 25051174Voduc N, la Porte C, Tessier C, Mallick R, Cameron DW. Effect of resveratrol on exercise capacity: a randomized placebo-controlled crossover pilot study. Appl Physiol Nutr Metab. 2014 Oct;39(10):1183-7. doi: 10.1139/apnm-2013-0547. Epub 2014 Apr 30.
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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.
Nha Voduc, MD principal investigator
The Ottawa Hospital, The Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol in people with Sedentary Lifestyle, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 5 inclusion and 34 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 23 Jun 2014. 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 Canada. 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.
What does this 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.
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 from baseline in duration of constant load exercise (time frame: Phase I: Baseline and 4 weeks; Phase II (cross-over phase): 6 weeks and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615445, which also lists 1 linked publication.
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 23 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.