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

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: Active, not recruiting
• Conditions: Exercise; Vasodilation; Healthy Adults
• Intervention / Treatment: Dietary supplement: Oral administration

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: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Flow mediated dilation (FMD ; %)	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

Outcome Measure	Measure Description	Time Frame
Fraction exhaled nitric oxyde (FeNO ; ppb)	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)	Ergometer	During exercise session (5 minutes intervals)
Heart rate (bpm)	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)	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)	enzymo-amperometric ; fingertip	During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)
Perceived exertion (1-10 scale)	Borg scale	During exercise session (5 minutes intervals)
Oximetry (SpO2, %)	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)	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))	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)	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

• Sponsor: Nexira
• Collaborators: CEP - Centre d'Expertise de la Performance Gilles Cometti

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): April 27, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise, Vasodilation, Vinitrox
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Aneurysm; Motor Activity; Therapeutics; Drug Administration Routes; Drug Therapy; Administration, Oral
• Other Study ID 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