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Completed

NCT Number: NCT01334138

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

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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: after 4 weeks

Secondary outcomes

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

    Time frame: after 4 weeks

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 12, 2011
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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