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

My Goodlife SAS100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

100

Conditions

Blood Pressure

Interventions

Sodium bicarbonate-rich mineral waterOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Institut de Diabétologie Et Nutrition Du Centre

Mainvilliers, France

Outcomes

Primary Outcomes

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.

Time frame: Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45

Secondary Outcomes

Sodium intake

The sodium intake per day is assessed using two three-day food records and the ExSel test.

Time frame: Day 1 to Day 15 - Day 31 to Day 45

Data from ClinicalTrials.gov

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