Acute Effect of Polyphenols Supplementation on Endothelial Function and Exercise Related Markers, in Physically Active Healthy Volunteers. (PolypOxy)

April 8, 2026 updated by: Nexira

Effets Aigus d'Une supplémentation en polyphénols (Vinitrox™) Contre Placebo Sur la Fonction endothéliale et la Performance Lors d'un Exercice à intensité modérée en Hypoxie Chez Des Volontaires Sains Physiquement Actifs.

To evaluate the effect of acute polyphenols supplementation on vasodilation and related markers along with exercise related markers (notably performance, respiratory exchanges, perceived exertion), before, during and after a hypoxic moderate-intensity exercise in healthy recreative volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Exercise session is an ergometer cycling workout performed under hypoxia condition equivalent to 3000 meters of altitude. Exercise session is composed of a warmup period followed by 20 minutes of cycling starting at 60% of individual maximal aerobic power.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Centre expertise de la performance Gilles Cometti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI < 27
  • Abdominal circumference < 94 cm
  • Stable exercise training program during past 2 months

Exclusion Criteria:

  • Total weekly exercise sessions < 4 hours OR > 8 hours
  • Drug or supplement intake during past one month that could interfere with study parameters
  • Volunteer suffering of respiratory or pulmonary condition
  • Volunteer exposed to an altitude > 2000 meters during at least 3 weeks for the past 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Maltodextrin
Dietary supplement: Oral administration
2 capsules the day before and 2 capsules 2 hours before the exercise session
Experimental: Polyphenols extract
Apple and grape polyphenols extract (Vinitrox™) - 250mg per capsule
Dietary supplement: Oral administration
2 capsules the day before and 2 capsules 2 hours before the exercise session

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flow mediated dilation (FMD ; %)
Time Frame: Before the exercise session (at rest under normoxia and hypoxia conditions)
Comparison of brachial artery diameter measured by ultrasound, before and after distal cuff-occlusion
Before the exercise session (at rest under normoxia and hypoxia conditions)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fraction exhaled nitric oxyde (FeNO ; ppb)
Time Frame: Before the exercise session (at rest under normoxia and hypoxia conditions) / After the exercise session (under normoxia condition).
Exhaled breath, quantified by electrochemical analyzer
Before the exercise session (at rest under normoxia and hypoxia conditions) / After the exercise session (under normoxia condition).
Maximal power and Total work (watt)
Time Frame: During exercise session (5 minutes intervals)
Ergometer
During exercise session (5 minutes intervals)
Heart rate (bpm)
Time Frame: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Thoracic belt
Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Blood pressure (mmHg)
Time Frame: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Wirst captation
Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Lactatemia (mmol/L)
Time Frame: During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
enzymo-amperometric ; fingertip
During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Perceived exertion (1-10 scale)
Time Frame: During exercise session (5 minutes intervals)
Borg scale
During exercise session (5 minutes intervals)
Oximetry (SpO2, %)
Time Frame: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
finger captation
Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Muscular oximetry (SmO2, saturation index)
Time Frame: During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Rectus femoris muscle captation
During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Respiratory gas exchanges (VO2, VCO2 ; mL/min/kg))
Time Frame: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Gas mask
Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Respiratory exchange ratio (RER)
Time Frame: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Gas mask
Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nexira

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEP - Centre d'Expertise de la Performance Gilles Cometti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIN06
  • ID-CRB : 2024-A01677-40 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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