Effect of Dietary Sodium Intake on Blood Pressure in Hypertensive Patients in Primary Care

NCT ID: NCT01334138

Last Updated: 2012-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-04-30

Brief Summary

There is strong evidence that our current consumption of salt is the major factor increasing blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams per day (g/d), whil the World Health Organization's recommendation is < 5 g/d.

The aims of the present study is to determine if the overconsumption of salt influences the bp in patients with uncontrolled hypertension or frequently elevated bp.

Each study subject will complete questionnaires, and their usual dietary salt intake is estimated from food composition on 3 completed food diaries. This is also compared with a 24-hour urine sample collection.

Based on these results, the study subject receives personal advice to decrease sodium consumption and will change the diet for at least 28 days. During this diet, bp will be measured and food diaries will be completed. After the intervention, a questionnaire and a 24-hour urine sample collection will be collected.

Conditions

Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

4-week diet, low in sodium

The study subjects go on a 4-week diet, low in sodium.

Group Type: EXPERIMENTAL

A 4-week diet, low in sodium.

Intervention Type: OTHER

Study subjects receive personal advice to decrease sodium consumption and will change his diet for 28 days.

Follow up is performed by measuring blood pressure, a 24-hour urine sample collection, diaries and questionnaires.

Interventions

A 4-week diet, low in sodium.

Study subjects receive personal advice to decrease sodium consumption and will change his diet for 28 days.

Follow up is performed by measuring blood pressure, a 24-hour urine sample collection, diaries and questionnaires.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adults, 50 years of age or older with changing blood pressure (bp) with or without drugs and patients with uncontrolled bp despite drugs
• An average systolic bp on 2 of the 3 previous visits of 140 mm Hg or more (130 mm Hg for diabetics) and an average diastolic bp of 80 to 100 mm Hg.
• Blood analysis (fasting glycaemia, creatinin, total cholesterol, high- density lipoprotein cholesterol) in the last 6 months
• At least 3 criteria of the following:

• using table salt
• 2-3/weeks consumption of prepared meals (butchery, warehouse...)
• 2-3/weeks consumption of effervescent tablet
• Daily consumption of cheese/cold cuts
• Daily consumption of salted butter/margarine
• 2-3/weeks consumption of smoked fish/meat
• 2-3/weeks consumption of bouillon cube-soup (self-made or preserved)
• 2-3/weeks consumption of cookies
• 2-3/weeks consumption of vegetables preserved in jars
• 2-3/weeks consumption of vegetable juice
• 2-3/weeks consumption of snacks (chips, cheese, nuts...)

Exclusion Criteria

• heart failure
• renal insufficiency
• secondary hypertension
• isolated systolic/diastolic hypertension
• bp difference of more than 10 mm Hg between left and right arm
• lactation or pregnancy
• active malignancy
• an active 'low in salt' diet
• changing the use of antihypertensive drugs or other medication that would affect bp for the last 4 weeks
• impaired cognitive functioning$
• planning a smoke cessation

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefaan Dehenauw, Ph.D, Professor

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

University Ghent

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2010/233

Identifier Type: -

Identifier Source: org_study_id