- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615445
Resveratrol Supplementation on Exercise in Healthy Sedentary Adults
A Pilot Randomized Controlled Clinical Trial of 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital -General Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Phase I: Baseline and 4 weeks; Phase II (cross-over phase): 6 weeks and 10 weeks
|
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.
|
Phase I: Baseline and 4 weeks; Phase II (cross-over phase): 6 weeks and 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Adverse Events
Time Frame: up to 10 weeks
|
up to 10 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nha Voduc, MD, The Ottawa Hospital, The Ottawa Hospital Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008540-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sedentary Lifestyle
-
Eindhoven University of TechnologyCompletedLifestyle | Lifestyle, Healthy | Lifestyle Risk Reduction | Lifestyle, SedentaryBelgium
-
Loughborough UniversityBritish Heart FoundationCompletedSedentary Lifestyle | Sedentary Behavior | Diet Habit
-
Taipei Medical University WanFang HospitalRecruitingLifestyle, SedentaryTaiwan
-
Brandeis UniversityNational Institute on Aging (NIA)Completed
-
University of California, San DiegoActive, not recruiting
-
University of MiamiCompletedSedentary LifestyleUnited States
-
University of PrimorskaInnorenew CoEUnknown
-
Chinese University of Hong KongCompletedVirtual Trainer System (3rd Version) for Physical Activity Promotion in Middle-aged Hong Kong AdultsSedentary LifestyleHong Kong
-
VakgroepBewegingsEnSportwetenschappenUniversity GhentCompleted
Clinical Trials on Resveratrol
-
University at BuffaloKaleida HealthTerminatedObesity | Insulin Resistance | Type 2 DiabetesUnited States
-
Jupiter Orphan Therapeutics Inc.National Institute on Aging (NIA)CompletedPharmacokinetics | Food-drug Interaction | SafetyUnited States
-
MaineHealthAmerican Heart AssociationActive, not recruitingCoronary Artery Disease | Diabetes Mellitus, Type 2United States
-
Bernard FiorettiCompleted
-
Maastricht University Medical CenterDSM Nutritional Products, Inc.Completed
-
Albert Einstein College of MedicineAmerican Diabetes AssociationCompletedImpaired Glucose ToleranceUnited States
-
Federal University of Rio Grande do SulCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Completed
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedCoronary Artery Disease | Blood Pressure | Heart Rate | Autonomic Nervous System DiseaseBrazil
-
Maastricht University Medical CenterDSM Nutritional Products, Inc.; Diabetes FondsCompleted
-
University of FloridaCompleted