Resveratrol Supplementation on Exercise in Healthy Sedentary Adults
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|ClinicalTrials.gov Identifier: NCT01615445|
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : June 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Sedentary Lifestyle||Drug: Resveratrol Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Pilot Randomized Controlled Clinical Trial of Resveratrol Supplementation on Exercise in Healthy Sedentary Adults|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Active Comparator: Resveratrol
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.
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.
Placebo Comparator: Placebo
Group B (n=6) Will receive placebo for 4 weeks, they will discontinue medication for two weeks. Then receive resveratrol for 4 weeks
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.
- 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.
- Number of participants with Adverse Events [ Time Frame: up to 10 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615445
|The Ottawa Hospital -General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Nha Voduc, MD||The Ottawa Hospital, The Ottawa Hospital Research Institute|