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ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.
Secondary objective are:
Volunteers are normotensive subjects divided into two equivalent groups. Group A subjects will begin their first 15-day period with the consumption of St-Yorre mineral water.
Group B will begin the first 15-day period by drinking tap water. After a washout period of 15 days, each group alternates with a new period of 15 days of water consumption monitoring: tap water for group A and mineral water St-Yorre for group B.
For each period salt intake and blood pressure are measured.Three-day food records are also performed for both 15-days periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A : sodium bicarbonate-rich mineral water and tap water | Experimental | First 15-days period with daily intake of 1.5l of sodium bicarbonate-rich mineral water. 15-days washout period Last 15-days period with daily intake of 1.5l of tap water. |
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| Group B : tap water and sodium bicarbonate-rich mineral water | Experimental | First 15-days period with daily intake of 1.5l of tap water. 15-days washout period Last 15-days period with daily intake of 1.5l of sodium bicarbonate-rich mineral water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate-rich mineral water | Other | St-Yorre, a sodium bicarbonate-rich mineral water, is a commercial mineral water that contains 4368 mg/l sodium bicarbonate. The study intends to evaluate the effect on blood pressure of the sodium bicarbonate intake due to this mineral water consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline mean number of systolic and diastolic blood pressure at 15 days | The primary endpoint is the difference between mean number of blood pressure of the volunteers drinking sodium bicarbonated-rich water during 15 days and the mean number of volunteers drinking tap water during 15 days. | Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Sodium intake | The sodium intake per day is assessed using two three-day food records and the ExSel test. | Day 1 to Day 15 - Day 31 to Day 45 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saïd Bekka, MD, PhD | INSTITUT DE DIABÉTOLOGIE ET NUTRITION DU CENTRE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Diabétologie Et Nutrition Du Centre | Mainvilliers | 28305 | France |
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Group A subjects: first 15-day period drinking a sodium bicarbonate-rich mineral water Group B subjects: first 15-day period drinking tap water Washout period of 15 days Group A subjects: last 15-day period drinking tap water Group B subjects: last 15-day period drinking a Sodium bicarbonate-rich mineral water
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