NCT07518758

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

March 27, 2026

Last Update Submit

April 8, 2026

Conditions

VasodilationExerciseHealthy Adults

Keywords

Exercise, Vasodilation, Vinitrox

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Fraction exhaled nitric oxyde (FeNO ; ppb)

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

  • 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)

  • Muscular oximetry (SmO2, saturation index)

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

  • Maximal power and Total work (watt)

    During exercise session (5 minutes intervals)

  • 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)

  • +5 more secondary outcomes

Study Arms (2)

Polyphenols extract

EXPERIMENTAL

Apple and grape polyphenols extract (Vinitrox™) - 250mg per capsule

Dietary Supplement: Oral administration

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Oral administration

Interventions

Oral administrationDIETARY_SUPPLEMENT

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

PlaceboPolyphenols extract

Eligibility Criteria

Age35 Years - 55 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre expertise de la performance Gilles Cometti

Dijon, 21000, France

Location

MeSH Terms

Conditions

AneurysmMotor Activity

Interventions

Administration, Oral

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 9, 2026

Study Start

September 1, 2025

Primary Completion

April 20, 2026

Study Completion

April 27, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)