Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects (ROX_TENSIO18)

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Status: Completed

Conditions: Blood Pressure

Treatments: Other: Sodium bicarbonate-rich mineral water

Study type: Interventional

Funder types: Industry

Identifiers

NCT04282512

MGL-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Sodium bicarbonate-rich mineral water

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

Experimental group

Description:

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.

Treatment:

Other: Sodium bicarbonate-rich mineral water