NCT02561325

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

September 8, 2015

Last Update Submit

July 25, 2016

Conditions

Healthy

Keywords

Blood pressureSodium ChlorideSodium Bicarbonate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • 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.

  • 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

  • +4 more secondary outcomes

Study Arms (2)

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.

Drug: Sodium Bicarbonate and Sodium chloride

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.

Drug: Sodium Bicarbonate and Sodium chloride

Interventions

Sodium Bicarbonate and Sodium chlorideDRUG
NaCI groupplacebo NaCI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Systolic Blood pressure between 130-160 mmHg and/or diastolic 90-100, not treated and/or family history of arterial high blood pressure (Father or Mother),
  • Between 18 and 75 years old
  • Asymptomatic on the cardiovascular plan,
  • Absence of known heart disorder,
  • Brachial Perimeter between 22 and 42 cms,
  • Creatinine clearance in the standards dating less than 12 months, (glomerular filtration rate \> 60 ml / mn / 1.73m²),
  • Agreeing to drink some sparkling water during the periods of study,
  • Effective method of birth control for women with childbearing potential
  • Cooperation and understanding enough to conform to the study obligations
  • Voluntary gives written informed consent to participate in the study
  • Affiliated at system of French social security
  • Inscription or acceptation of inscription in the national register of volunteers involved in trials.

You may not qualify if:

  • Treated by corticoids
  • Treated by prohibited medications
  • Pregnant or breastfeeding
  • Treated by anti-hypertensive drug
  • History of heart disease or ischemic heart disease
  • Lack of sinus rhythm
  • Renal insufficiency (glomerular filtration rate \> 60 ml / mn / 1.73m ²)
  • Uncontrolled hypertension (\> 160 / 100mmHg)
  • Incompatible comorbidity with the study
  • BMI \> 35 kg / m2
  • Invalidating cognitive disorders
  • Anxiety to use the device to measure blood pressure alone at home judged by the investigator
  • Diabetes (Type I and II)
  • Chronic alcoholism
  • Sports judged as intense (more than 3 hours per week of intense sports),
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Interventions

Sodium BicarbonateSodium Chloride

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Claude DUBRAY

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 28, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

FR(1)