Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects

Study Overview
=================
Brief Summary
-----------------
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: Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt intake Evaluation on blood pressure of the usual food groups that are the strongest contributors of salt intake.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of the Effect of Daily Consumption of Sodium Bicarbonate Water for 15 Days on Blood Pressure in Normotensive Subjects

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Other: Sodium bicarbonate-rich mineral water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal blood pressure between 90/60 and 140/90 mm Hg Usually drinks tap water; Knowing read and write French routinely, Possessing an internet connection at home, Possessing and knowing how to use a computer or tablet, Affiliated with a social security scheme Not Trust Having signed the informed consent letter Exclusion Criteria: Pregnant or lactating woman BMI greater than 35 kg / m² Heart failure History of cardiovascular disease Hypertension treated or untreated Renal failure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A : sodium bicarbonate-rich mineral water and tap water<br>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. | Other: Sodium bicarbonate-rich mineral water<br>* 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.<br>* Other names: St-Yorre mineral water;|
| Experimental: Group B : tap water and sodium bicarbonate-rich mineral water<br>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. | Other: Sodium bicarbonate-rich mineral water<br>* 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.<br>* Other names: St-Yorre mineral water;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, Blood pressure, Sodium bicarbonate