Comparison on Blood Pressure Effect of an Equivalent Sodium Intake, With Different Nature, for Hypertensive Subjects

NCT05108402 | Unknown

• 2 other identifiers: RBHP 2021 PICKERING 32021-A01134-37
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health \& Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day. In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ". "NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension. Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt. On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.

Conditions

Hypertension

Keywords

Sodium intake; Blood pressure; high blood pressure; bicarbonate sodium; chloride sodium; NaCl sensitive

Outcome Measures

Primary Outcomes (1)

• Change from mean blood pressure (MBP) at Day 21

  Comparison between blood pressure data recorded by the volunteer between the 2 weeks of treatment (measurement during 2 days before Day 7 and 2 days before Day 21). Recording of systolic and diastolic blood pressure will be made by the patient at home with the Microlife BP A200 device, in the morning and evening. Comparison of the data collected from these 2 weeks of treatment will allow us to meet the main objective of the study.

  Day 21

Secondary Outcomes (17)

• Change from mean blood pressure (MBP) at Day -7

  Day -7

• Weight

  Day -28, Day -21, Day -14, Day -7, Day 7 and Day 21

• Body composition analysis

  Day -21, Day -14, Day -7, Day 7 and Day 21

• Optional genotyping

  One time at Day -28

• Plasma renin dosage on fasted state

  Day -28, Day -14, Day -7, Day 7 and Day 21

Study Arms (3)

Bottle of water

EXPERIMENTAL

After inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt.

Diagnostic Test: Phenotyping; Dietary Supplement: Drug intake

Salt sachet

ACTIVE COMPARATOR

After inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt.

Diagnostic Test: Phenotyping; Dietary Supplement: Drug intake

No treatment

OTHER

After inclusion in the study, the patients are phenotyped between V1 and V4. Following this, they will be separated into 2 groups: "NaCl sensitive" patients and "non-NaCl sensitive" patients. The non-sensitive group will drop out of the study, while the others will be randomized to one of the 2 treatment arms: bottle of water or sachet of salt.

Diagnostic Test: Phenotyping

Interventions

Phenotyping DIAGNOSTIC_TEST

After inclusion in the study, between V1 and V4, patients will be phenotyped among: "NaCl sensitive" patients and "non-NaCl sensitive" patients. they will have a low sodium diet for 2 weeks. The first week without salt supplementation and the second with salt supplementation. At the end of V4, if patient is "NaCl sensitive" he will continue into treatment period and go through randomization, and for patient "non-NaCl sensitive" they will drop out of study.

Bottle of water; No treatment; Salt sachet

Drug intake DIETARY_SUPPLEMENT

After being phenotyped, "NaCl sensitive" patients will continue the study in one of the 2 treatments arms : royal water (bottle) or salt sachet.

Bottle of water; Salt sachet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systolic blood pressure between 135-160 mmHg and diastolic 85-100 in self-measurement, untreated or treated but not balanced under treatment,
• Father or mother hypertensive,
• Weight ≥ 50 kg
• Absence of known heart disease,
• Brachialis perimeter between 22 and 42 cm,
• Creatinine clearance within the standards dating from less than 12 months, (GFR\> 60ml / min / 1.73m²),
• Agreeing to drink sparkling water during one of the study periods,
• Effective contraception for female subjects of childbearing age,
• Cooperation and understanding sufficient to comply with the requirements of the test,
• Affiliated with a Social Security scheme,
• Agreeing to give written consent,
• Registration or acceptance of registration in the national register of volunteers participating in research.

You may not qualify if:

• Consumption of more than 5g/day of salt in the protocol diet (evaluated by natriuresis analyzed in V3)
• Systemic corticosteroid therapy
• Taking prohibited drugs (see list) and at the judgment of the investigator.
• Suffering from pulmonary hypertension
• Woman of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman,
• History of cardiomyopathy or ischemic heart disease,
• Absence of sinus rhythm,
• Renal failure (DFG \<60 ml/min/1.73m²),
• Comorbidity incompatible with the study,
• BMI\> 35 kg/m2,
• Disabling cognitive disorders,
• Anxiety when taking measurements alone at home at the judgment of the investigator,
• Diabetes (Type I and II)
• Chronic alcoholism,
• Sports activity deemed to be intense (more than 3 hours / week of intense sport),

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Platform of Clinical Investigation / Clinical Investigation Center French Institute of Health and Medical Research-1405 University Hospital

Clermont-Ferrand, Auvergne, 63000, France

Location

Related Links

• Clinical trial link for previous clinical trial on the same subject

MeSH Terms

Conditions

Hypertension

Interventions

Immunophenotyping

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Gisele PICKERING, MD

  Platform of Clinical Investigation/Clinical Investigation Center French Institute of Health and Medical Research-1405 63000 Clermont-Ferrand FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE, PharmD

CONTACT

04 73 75 11 95; drci@chu-clermontferrand.fr

Study Design

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

Model Details: Single-center, randomized study, organized in 2 stages.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: November 4, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 4, 2021

Record last verified: 2021-09

Locations

FR (1)