Resveratrol Supplementation on Exercise in Healthy Sedentary Adults

NCT ID: NCT01615445

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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 Type: ACTIVE_COMPARATOR

Resveratrol

Intervention Type: 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.

Placebo

Group B (n=6) Will receive placebo for 4 weeks, they will discontinue medication for two weeks. Then receive resveratrol for 4 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

Resveratrol

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.

Intervention Type: DRUG

placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nha Voduc, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital, The Ottawa Hospital Research Institute

Locations

The Ottawa Hospital -General Campus

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 25051174 (View on PubMed)

Related Links

http://www.nrcresearchpress.com/doi/abs/10.1139/apnm-2013-0547

click here to view trial results

Other Identifiers

2008540-01H

Identifier Type: -

Identifier Source: org_study_id