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

NCT01334138 | Completed

• 1 other identifier: 2010/233
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

hypertension; sodium; diet

Outcome Measures

Primary Outcomes (1)

• Measurement of blood pressure after a 4-week diet, low in sodium.

  after 4 weeks

Secondary Outcomes (1)

• Life style change after a 4-week diet, low in sodium.

  after 4 weeks

Study Arms (1)

4-week diet, low in sodium

EXPERIMENTAL

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

Other: A 4-week diet, low in sodium.

Interventions

A 4-week diet, low in sodium. 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.

4-week diet, low in sodium

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

University Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Hypertension

Interventions

Diet; Sodium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Stefaan Dehenauw, Ph.D, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 12, 2011
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

BE (1)