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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-28

Study Completion Date

2019-12-20

Brief Summary

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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:

* 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.

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Detailed Description

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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.

Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group A : sodium bicarbonate-rich mineral water and tap water

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.

Group Type EXPERIMENTAL

Sodium bicarbonate-rich mineral water

Intervention Type 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.

Group B : tap water and sodium bicarbonate-rich mineral water

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.

Group Type EXPERIMENTAL

Sodium bicarbonate-rich mineral water

Intervention Type 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.

Interventions

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Sodium bicarbonate-rich mineral water

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.

Intervention Type OTHER

Other Intervention Names

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St-Yorre mineral water

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes