Oral Sodium Blood Pressure in Normal Weight, Overweight and Obese Volunteers (PLADSEL)

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Other: sodium chloride; Other: Methylcellulose crystalline

Study type: Interventional

Funder types: Other

Identifiers

NCT01532401

PLADSEL 2010-023410-31

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 6 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

51 participants in 2 patient groups, including a placebo group

chlorure de sodium

Experimental group

Treatment:

Other: sodium chloride

Methylcellulose

Placebo Comparator group

Treatment:

Other: Methylcellulose crystalline