Blood PressureROX_TENSIO18NCT04282512
Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects
A study testing Sodium bicarbonate-rich mineral water in people with Blood Pressure, run by My Goodlife SAS at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Sodium bicarbonate-rich mineral water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating woman
- BMI greater than 35 kg / m²
- Heart failure
- History of cardiovascular disease
- Hypertension treated or untreated
- Renal failure.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Diabétologie Et Nutrition Du Centre
Mainvilliers, 28305
About this study
Official title: 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.
Read the 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
- Blood Pressure
- Being tested
- Sodium bicarbonate-rich mineral water
- Keywords
- Nutrition, Blood pressure, Sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate-rich mineral waterOther
Also called St-Yorre 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sodium bicarbonate-rich mineral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The sodium intake per day is assessed using two three-day food records and the ExSel test.
Measured: Day 1 to Day 15 - Day 31 to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start28 Jun 2019
- Primary completion15 Nov 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- My Goodlife SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saïd Bekka, MD, PhD, Principal investigator, INSTITUT DE DIABÉTOLOGIE ET NUTRITION DU CENTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282512
- Sponsor's protocol ID
- MGL-003
- Acronym
- ROX_TENSIO18
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Daily Consumption of Sodium Bicarbonate Water for 15 Days on Blood Pressure in Normotensive Subjects
- ClinicalTrials.gov ID
- NCT04282512
- Acronym / sponsor ID
- ROX_TENSIO18 / MGL-003
- Conditions
- Blood Pressure
- Keywords
- Nutrition, Blood pressure, Sodium bicarbonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- My Goodlife SASIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A : sodium bicarbonate-rich mineral water and tap water | Experimental | Other: Sodium bicarbonate-rich mineral waterFirst 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. |
| Group B : tap water and sodium bicarbonate-rich mineral water | Experimental | Other: Sodium bicarbonate-rich mineral waterFirst 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- Pregnant or lactating woman
- BMI greater than 35 kg / m²
- Heart failure
- History of cardiovascular disease
- Hypertension treated or untreated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonate-rich mineral waterAlso: St-Yorre 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. | Other | Group A : sodium bicarbonate-rich mineral water and tap water, Group B : tap water and sodium bicarbonate-rich mineral water |
Primary outcome
Change from baseline mean number of systolic and diastolic blood pressure at 15 days
Time frame: 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.
1 secondary outcome
Sodium intake
Time frame: Day 1 to Day 15 - Day 31 to Day 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saïd Bekka, MD, PhD principal investigator
INSTITUT DE DIABÉTOLOGIE ET NUTRITION DU CENTRE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate-rich mineral water in people with Blood Pressure, run by My Goodlife SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline mean number of systolic and diastolic blood pressure at 15 days (time frame: Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.