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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Other: Sodium bicarbonate-rich mineral water

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Mainvilliers, France, 28305
    • Institut de diabétologie et Nutrition du Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: St-Yorre mineral water
Experimental: 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.	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.; Other Names: St-Yorre mineral water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: My Goodlife SAS
• Investigators: Principal Investigator: Saïd Bekka, MD, PhD, Institut de diabétologie et Nutrition du Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Nutrition; Blood pressure; Sodium bicarbonate
• Other Study ID Numbers: MGL-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No