Clinical trial NCT01334138: Effect of Dietary Sodium Intake on Blood Pressure in Hypertensive Patients in Primary Care
Official title: Effect of Dietary Sodium Intake on Blood Pressure in Hypertensive Patients in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Hypertension
Keywords: hypertension
sodium
diet
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2011-04-12
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Measurement of blood pressure after a 4-week diet, low in sodium.
timeFrame: after 4 weeks
Secondary outcomes:
measure: Life style change after a 4-week diet, low in sodium.
timeFrame: after 4 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
Study officials:
affiliation: University Ghent
name: Stefaan Dehenauw, Ph.D, Professor
role: PRINCIPAL_INVESTIGATOR
References: