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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07518758
Acronym
PolypOxy
Enrollment
38
Registered
2026-04-09
Start date
2025-09-01
Completion date
2026-04-27
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasodilation, Exercise, Healthy Adults

Keywords

Exercise, Vasodilation, Vinitrox

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTOral administration

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

Sponsors

Nexira
Lead SponsorINDUSTRY
CEP - Centre d'Expertise de la Performance Gilles Cometti
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Flow mediated dilation (FMD ; %)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

MeasureTime frameDescription
Fraction exhaled nitric oxyde (FeNO ; ppb)Before the exercise session (at rest under normoxia and hypoxia conditions) / After the exercise session (under normoxia condition).Exhaled breath, quantified by electrochemical analyzer
Oximetry (SpO2, %)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
Muscular oximetry (SmO2, saturation index)During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)Rectus femoris muscle captation
Maximal power and Total work (watt)During exercise session (5 minutes intervals)Ergometer
Respiratory gas exchanges (VO2, VCO2 ; mL/min/kg))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
Respiratory exchange ratio (RER)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
Heart rate (bpm)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
Blood pressure (mmHg)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
Lactatemia (mmol/L)During exercise session (5 minutes intervals) / After the exercise session (under normoxia condition)enzymo-amperometric ; fingertip
Perceived exertion (1-10 scale)During exercise session (5 minutes intervals)Borg scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026