Resveratrol Supplementation on Exercise in Healthy Sedentary Adults

NCT01615445 | Completed Phase 2

• 1 other identifier: 2008540-01H
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  up to 10 weeks

Study Arms (2)

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.

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

Drug: placebo

Interventions

Resveratrol DRUG

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.

Resveratrol

placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital -General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25051174 RESULT

Related Links

• click here to view trial results

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Nha Voduc, MD

  The Ottawa Hospital, The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 8, 2012
• Study Start: February 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

CA (1)