HealthyNCT03214276
Effects of Polyphenols Supplementation on Cycling Endurance
A study testing Vinitrox polyphenols in people with Healthy, run by University of Burgundy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vinitrox polyphenols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index lower than 27 and waist size lower than 94 cm
- physical activity higher than 2 hours a week
- written informed consent
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Vinitrox polyphenols, Placebo
- Keywords
- polyphenols, cycling, endurance, aerobic, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinitrox polyphenolsDietary supplement
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)
PlaceboDietary supplement
Made with maltodextrin. It was administrated the night and the morning before the endurance test (oral administration).
| Study group | Role | What they receive |
|---|---|---|
| Polyphenols | Active comparator | The preceding night and one hour before the endurance test, participants were asked to absorb two capsules of 250 mg of polyphenols (Vinitrox™) Receives: Dietary Supplement: Vinitrox polyphenols |
| placebo | Placebo comparator | 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). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exhaustion
Maximal duration during a cycling aerobic exercise (70% of maximal aerobic power)
Measured: The total duration of the aerobic exercise (during the cycling aerobic exercise)
Secondary outcomes (4)
Heart rate
Heart rate using a polar belt
Measured: 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
oxygen intake using a portable gaz exchange analyzer
Measured: 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
blood pressure measured at the arm
Measured: Immediately before the endurance test, immediately after the endurance test
Pain sensation
Pain sensation using a visual analog scale
Measured: Immediately after the endurance exercise and 48 hours after the endurance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Jan 2012
- Primary completion1 Jun 2012
- Study completion1 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Babault, University of Burgundy
- Investigators
- Nicolas Babault, PhD, Principal investigator, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214276
- Sponsor's protocol ID
- CEN1143
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Specific Grape and Apple Polyphenols Supplementation on Cycling Endurance Performance
- ClinicalTrials.gov ID
- NCT03214276
- Acronym / sponsor ID
- CEN1143
- Conditions
- Healthy
- Keywords
- polyphenols, cycling, endurance, aerobic, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jul 2012 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenols | Active comparator | Dietary Supplement: Vinitrox polyphenolsThe preceding night and one hour before the endurance test, participants were asked to absorb two capsules of 250 mg of polyphenols (Vinitrox™) |
| placebo | Placebo comparator | Dietary Supplement: PlaceboThe 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). |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index lower than 27 and waist size lower than 94 cm
- physical activity higher than 2 hours a week
- written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinitrox polyphenolsVinitrox™ (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) | Dietary supplement | Polyphenols |
| PlaceboMade with maltodextrin. It was administrated the night and the morning before the endurance test (oral administration). | Dietary supplement | placebo |
Primary outcome
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)
4 secondary outcomes
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
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
blood pressure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Babault, PhD principal investigator
University of Burgundy
Questions about this trial
What is this clinical trial studying?
A study testing Vinitrox polyphenols in people with Healthy, run by University of Burgundy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to exhaustion (time frame: The total duration of the aerobic exercise (during the cycling aerobic exercise)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.