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

Blood Pressure Clinical Trial

— ROX_TENSIO18  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282512
• Other study ID #: MGL-003
• Status: Completed
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2020
• Source: My Goodlife SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 20, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Institut de Diabétologie Et Nutrition Du Centre	Mainvilliers

Sponsors (1)

Lead Sponsor	Collaborator
My Goodlife SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45
Secondary	Sodium intake	The sodium intake per day is assessed using two three-day food records and the ExSel test.	Day 1 to Day 15 - Day 31 to Day 45