NCT03214276

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 6, 2017

Last Update Submit

July 7, 2017

Conditions

Keywords

polyphenolscyclingenduranceaerobicpain

Outcome Measures

Primary Outcomes (1)

  • Time to exhaustion

    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 Outcomes (4)

  • Heart rate

    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

    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

    Immediately before the endurance test, immediately after the endurance test

  • Pain sensation

    Immediately after the endurance exercise and 48 hours after the endurance test

Study Arms (2)

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™)

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).

Dietary Supplement: Placebo

Interventions

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)

Polyphenols
PlaceboDIETARY_SUPPLEMENT

Made with maltodextrin. It was administrated the night and the morning before the endurance test (oral administration).

placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index lower than 27 and waist size lower than 94 cm
  • physical activity higher than 2 hours a week
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Babault, PhD

    University of Burgundy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 11, 2017

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share