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Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread.
In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant."
"Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension.
In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium.
Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.
Pre-selection: Clinical Pharmacology Center or Cardiology department
Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center
Phenotyping period : (192 subjects)
All the 192 subjects will realize the 3 first visits in order to determine if yes or no the subjects are "Sodium sensitive".
Selection - Visit 1 : General practitioner's office or Clinical Pharmacology Center
Visit 2: General practitioner's office or Clinical Pharmacology Center
Visit 3 : General practitioner's office or Clinical Pharmacology Center
Determination of the subjects " sodium sensitive ". Sodium sensitive subjects will continue the study and non-sodium sensitive subjects will stop the study.
Wash-out period n°1 (2 weeks at least) pursuit of the dietary instructions.
Cross over study - Clinical Pharmacology Center :Center (48 subjects)
All the subjects will realize the 4 visits of the cross over study, and will received Nacl and placebo according to the randomisation plan.
Visit 4 and visit 6 contained the same interventions for the participant (exept the consultation with the dietetician) and visit 5 et 7 are the same regarding the interventions for the participant.
First period
Visit 4 - Day 0 :
6.51 g of NaCl per day to distribute on the various meals + 1.5 liters of spring water (poor in sodium) to drink each day, Or placebo NaCl every day to distribute on the various meals + 1.5 liters of spring water (with sodium bicarbonate) to drink each day.
Every day during 14 days The first take of treatment will be done on the Clinical Pharmacology Center
- Delivery of the urinary bottle for the twenty-four-hour urine analysis before Visit 5
Visit 5 (Day 14) :
Wash-out 2 (at least 2 weeks) pursuit of the dietary instructions.
Second study period
Visit 6 (day28) - beginning period 2
Visite 7 (Day42) - end of period 2 and end of study
This second period is the same as the first period, except that the subject will not have the consultation with the dietetician and will receive the other study treatment according to the randomization plan.
Ancillary Study This trial contains an ancillary study of genotypage (optional with specific consent of the subject) with the aim of the confrontation with the phenotyping.
For that purpose, a blood sample will be made in the period of selection on the subject who gives their consent, in the same time of the blood sample for renal biology at visit 1.
These results would allow to identify biomarkers of blood pressure sensibility at the sodium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaCI group | Experimental | a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt. |
|
| placebo NaCI | Placebo Comparator | a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate and Sodium chloride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average value of the mean blood pressures | Average value of the mean blood pressures, collected with the device Microlife BP A200, in the morning and evening during the last 3 days of each of the 2 periods of treatment of 14 days. | during the last 3 days of each of the 2 periods of treatment of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Value of Aortic Systolic Pressure (SP) with device Sphygmocor ®, | during the last 3 days of each of the 2 periods of treatment of 14 days. | |
| Value of Pulse Pressure (PP), with device Sphygmocor ®, | during the last 3 days of each of the 2 periods of treatment of 14 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claude DUBRAY | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| Value of the Increase Index (AIX) with the Sphygmocor ®, | during the last 3 days of each of the 2 periods of treatment of 14 days. |
| Value of the Pusle Wave Velocity with the Sphygmocor ®, | during the last 3 days of each of the 2 periods of treatment of 14 days. |
| Biological assay of Renine (pg/ml) | during the last 3 days of each of the 2 periods of treatment of 14 days |
| Values of fat mass, dry mass and water by impedancemetry. | during the last 3 days of each of the 2 periods of treatment of 14 days |
| Biological assay Aldostéron (pg/ml) | during the last 3 days of each of the 2 periods of treatment of 14 days |
| Biological assay Angiotensine II (UECA) | during the last 3 days of each of the 2 periods of treatment of 14 days |
| Biological Assay of the Endotheliales microparticles (nb/µl) | during the last 3 days of each of the 2 periods of treatment of 14 days |
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
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