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

NCT04282512 | Completed

• 1 other identifier: MGL-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Nutrition; Blood pressure; Sodium bicarbonate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sodium intake

  Day 1 to Day 15 - Day 31 to Day 45

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Sodium bicarbonate-rich mineral water OTHER

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.

Also known as: St-Yorre mineral water

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating woman
• BMI greater than 35 kg / m²
• Heart failure
• History of cardiovascular disease
• Hypertension treated or untreated
• Renal failure.

Sponsors & Collaborators

• My Goodlife SAS: lead

Study Sites (1)

Institut de Diabétologie Et Nutrition Du Centre

Mainvilliers, 28305, France

Location

Study Officials

• Saïd Bekka, MD, PhD

  INSTITUT DE DIABÉTOLOGIE ET NUTRITION DU CENTRE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: June 28, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 20, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)