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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04282512

Acronym

ROX_TENSIO18

Enrollment

100

Registered

2020-02-24

Start date

2019-06-28

Completion date

2019-12-20

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

Nutrition, Blood pressure, Sodium bicarbonate

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.

Interventions

OTHERSodium 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline mean number of systolic and diastolic blood pressure at 15 days	Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45	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.

Secondary

Measure	Time frame	Description
Sodium intake	Day 1 to Day 15 - Day 31 to Day 45	The sodium intake per day is assessed using two three-day food records and the ExSel test.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026