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VasodilationPolypOxyNCT07518758

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

A study testing Oral administration in people with Vasodilation and Exercise, run by Nexira at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Vasodilation, Exercise, Healthy Adults
What is being tested?
Oral administration
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteFrance
Study dates
1 Sep 2025to 27 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre expertise de la performance Gilles Cometti

    Dijon, 21000

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Oral administration
Keywords
Exercise, Vasodilation, Vinitrox
Medical subject headings
Aneurysm, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral administrationDietary supplement

    2 capsules the day before and 2 capsules 2 hours before the exercise session

Study groups in NCT07518758
Study groupRoleWhat they receive
Polyphenols extractExperimentalApple and grape polyphenols extract (Vinitrox™) - 250mg per capsule
Receives: Dietary Supplement: Oral administration
PlaceboPlacebo comparatorMaltodextrin
Receives: Dietary Supplement: Oral administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flow mediated dilation (FMD ; %)

    Comparison of brachial artery diameter measured by ultrasound, before and after distal cuff-occlusion

    Measured: Before the exercise session (at rest under normoxia and hypoxia conditions)

Secondary outcomes (10)

  1. Fraction exhaled nitric oxyde (FeNO ; ppb)

    Exhaled breath, quantified by electrochemical analyzer

    Measured: Before the exercise session (at rest under normoxia and hypoxia conditions) / After the exercise session (under normoxia condition).

  2. Oximetry (SpO2, %)

    finger captation

    Measured: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

  3. Muscular oximetry (SmO2, saturation index)

    Rectus femoris muscle captation

    Measured: During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

  4. Maximal power and Total work (watt)

    Ergometer

    Measured: During exercise session (5 minutes intervals)

  5. Respiratory gas exchanges (VO2, VCO2 ; mL/min/kg))

    Gas mask

    Measured: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

  6. Respiratory exchange ratio (RER)

    Gas mask

    Measured: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

  7. Heart rate (bpm)

    Thoracic belt

    Measured: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

  8. Blood pressure (mmHg)

    Wirst captation

    Measured: Before the exercise session (at rest under normoxia and hypoxia conditions) / During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

  9. Lactatemia (mmol/L)

    enzymo-amperometric ; fingertip

    Measured: During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)

  10. Perceived exertion (1-10 scale)

    Borg scale

    Measured: During exercise session (5 minutes intervals)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start1 Sep 2025
  3. Primary completion20 Apr 2026 (estimated)
  4. Study completion27 Apr 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518758
Sponsor's protocol ID
VIN06
Other IDs
ID-CRB : 2024-A01677-40
Acronym
PolypOxy
Status last verified
Apr 2026
First submitted
27 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oral administration in people with Vasodilation and Exercise, run by Nexira at 1 site in France.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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?

Flow mediated dilation (FMD ; %) (time frame: Before the exercise session (at rest under normoxia and hypoxia conditions)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07518758.

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 13 Apr 2026.

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