- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214276
Effects of Polyphenols Supplementation on Cycling Endurance
Effects of Acute Specific Grape and Apple Polyphenols Supplementation on Cycling Endurance Performance
Endurance performance during high intensive exercises is mainly determined by the capacity of the aerobic metabolism. It generally induces muscle fatigue defined as the reversible decline in skeletal muscle contractile performance. Fatigue is multifactorial and is often associated with many physiological parameters including reduced neural input and disruptive metabolic changes in skeletal muscles such as lactic acidosis and the production of oxidative free radicals. Moreover, it could lead to oxidative stress as a result of an imbalance between reactive oxygen species (ROS) production and intrinsic antioxidant defense.
To alleviate oxidative stress, some ergogenic strategies have been tested. Numerous studies have reported that different types of supplementation such as selenium, vitamin E, vitamin C or polyphenols were of interest to protect against these mechanisms. Indeed, although some studies demonstrated no or harmful effects, most studies observed positive effects of antioxidants on oxidative stress or performance. More particularly, polyphenols, have great antioxidant capabilities and protective effects and it increases the synthesis and bioavailability of nitric oxide (NO)which is well known to be the most important mediator of vasodilation. To date, most of the studies exploring the effects of polyphenols on exercise investigated several days or weeks of supplementations on vascular, blood parameters (blood pressure, NO concentration, oxidative stress markers) or endurance performance. Conflicting results are often obtained. Only few studies investigated the effects of a single intake on immediate performance and recovery capacity. Therefore, the present work aimed to study the effects of an acute intake of a specific profile polyphenols from grape and apple on physical performances. More specifically, performance, in the present study, referred to high intensity cycling exercise until exhaustion revealing the capacity to maintain a constant strong effort hereafter named endurance. The hypothesis was that an acute of polyphenols would increase the time to exhaustion during a high intensity cycling exercise.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index lower than 27 and waist size lower than 94 cm
- physical activity higher than 2 hours a week
- written informed consent
Exclusion Criteria:
- more than 6 hours training a week, regularly trained in aerobic activities
- asthmatic, smokers or under medicinal drugs
- dietary supplement, sports drink, special dietary food or functional food, of any kind, liable or presented as liable to enhance physical performances
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Polyphenols
The preceding night and one hour before the endurance test, participants were asked to absorb two capsules of 250 mg of polyphenols (Vinitrox™)
|
Vinitrox™ (Nexira - France) is a combination of specific profile polyphenols from grape and apple.
The main polyphenol classes are proanthocyanidins (as catechins, B2 dimer), phenolic acids (as chlorogenic acids, gallic acids) and anthocyanins (as malvidin-3-glucoside).
It was administrated the night and the morning before the endurance test (oral administration)
|
Placebo Comparator: placebo
The preceding night and one hour before the endurance test, participants were asked to absorb two capsules of placebo (similar appearance and flavour than active comparator).
|
Made with maltodextrin.
It was administrated the night and the morning before the endurance test (oral administration).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to exhaustion
Time Frame: The total duration of the aerobic exercise (during the cycling aerobic exercise)
|
Maximal duration during a cycling aerobic exercise (70% of maximal aerobic power)
|
The total duration of the aerobic exercise (during the cycling aerobic exercise)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: Immediately before the endurance test, immediately after the endurance test and continuously recorded during three minutes during the recovery to determine half-recovery time
|
Heart rate using a polar belt
|
Immediately before the endurance test, immediately after the endurance test and continuously recorded during three minutes during the recovery to determine half-recovery time
|
Gaz exchange
Time Frame: Immediately before the endurance test, immediately after the endurance test and continuously recorded during three minutes during the recovery to determine half-recovery time
|
oxygen intake using a portable gaz exchange analyzer
|
Immediately before the endurance test, immediately after the endurance test and continuously recorded during three minutes during the recovery to determine half-recovery time
|
blood pressure
Time Frame: Immediately before the endurance test, immediately after the endurance test
|
blood pressure measured at the arm
|
Immediately before the endurance test, immediately after the endurance test
|
Pain sensation
Time Frame: Immediately after the endurance exercise and 48 hours after the endurance test
|
Pain sensation using a visual analog scale
|
Immediately after the endurance exercise and 48 hours after the endurance test
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CEN1143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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