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| ID | Type | Description | Link |
|---|---|---|---|
| ID-CRB : 2024-A01677-40 | Registry Identifier | ANSM |
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| Name | Class |
|---|---|
| CEP - Centre d'Expertise de la Performance Gilles Cometti | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyphenols extract | Experimental | Apple and grape polyphenols extract (Vinitroxâ„¢) - 250mg per capsule |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral administration | Dietary Supplement | 2 capsules the day before and 2 capsules 2 hours before the exercise session |
|
| 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) |
| 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). |
| Oximetry (SpO2, %) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre expertise de la performance Gilles Cometti | Dijon | 21000 | France |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000284 | Administration, Oral |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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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) |
| Maximal power and Total work (watt) | Ergometer | During exercise session (5 minutes intervals) |
| 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) |
| 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) |