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CompletedNCT04282512

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
My Goodlife SAS · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSodium bicarbonate-rich mineral waterSt-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.

Timeline

Start date
2019-06-28
Primary completion
2019-11-15
Completion
2019-12-20
First posted
2020-02-24
Last updated
2020-02-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04282512. Inclusion in this directory is not an endorsement.