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Completed

NCT Number: NCT01615445

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital -General Campus

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of participants with Adverse Events

    Time frame: up to 10 weeks

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

A Pilot Randomized Controlled Clinical Trial of Resveratrol Supplementation on Exercise in Healthy Sedentary Adults

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 8, 2012
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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