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Active, Not Recruiting

NCT Number: NCT07518758

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Vasodilation Aneurysm Behavior Cardiovascular Diseases Exercise Healthy Adults Motor Activity Vascular Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre expertise de la performance Gilles Cometti

Dijon, 21000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral administration

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Muscular oximetry (SmO2, saturation index)

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

    Rectus femoris muscle captation

  4. Maximal power and Total work (watt)

    Time frame: During exercise session (5 minutes intervals)

    Ergometer

  5. 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

  6. 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

  7. 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

  8. 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

  9. Lactatemia (mmol/L)

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

    enzymo-amperometric ; fingertip

  10. Perceived exertion (1-10 scale)

    Time frame: During exercise session (5 minutes intervals)

    Borg scale

Sponsors and collaborators

Lead sponsor

Nexira

Industry

Collaborators

  • CEP - Centre d'Expertise de la Performance Gilles Cometti

Registry information

Official study 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.

Acronym: PolypOxy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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