Resveratrol Supplementation on Exercise in Healthy Sedentary Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01615445
First received: May 25, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Sedentary Lifestyle
Drug: Resveratrol
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Pilot Randomized Controlled Clinical Trial of Resveratrol Supplementation on Exercise in Healthy Sedentary Adults

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The aerobic capacity (peak VO2)is assessed by incremental exercise tests.


Secondary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: up to 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: February 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615445

Locations
Canada, Ontario
The Ottawa Hospital -General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Nha Voduc, MD The Ottawa Hospital, The Ottawa Hospital Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01615445     History of Changes
Other Study ID Numbers: 2008540-01H
Study First Received: May 25, 2012
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014