NCT01532401

Brief Summary

The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese. Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

October 11, 2016

Status Verified

February 1, 2012

Enrollment Period

3.5 years

First QC Date

February 9, 2012

Last Update Submit

October 10, 2016

Conditions

Obesity

Keywords

Blood pressure

Study Arms (2)

chlorure de sodium

EXPERIMENTAL
Other: sodium chloride

Methylcellulose

PLACEBO COMPARATOR
Other: Methylcellulose crystalline

Interventions

sodium chlorideOTHER

sodium chloride 500mg

chlorure de sodium
Methylcellulose crystallineOTHER

Methylcellulose 37 ml

Methylcellulose

Eligibility Criteria

Age6 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Informed consent
  • Age 18-45 for adults and 6-8 for children

You may not qualify if:

  • African ethnicity (known to affect blood pressure sensitivity to salt)
  • Chronic condition affecting blood pressure
  • Diabetes (known to affect blood pressure sensitivity to salt)
  • Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poitiers University Hospital

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Samy HADJADJ, MD

    CHU DE POITIERS-Service d'endocrinologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 14, 2012

Study Start

March 1, 2011

Primary Completion

September 1, 2014

Last Updated

October 11, 2016

Record last verified: 2012-02

Locations

FR(1)