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CompletedNCT01334138Updated Apr 23, 2012

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

An interventional study of A 4-week diet, low in sodium. in Arterial Hypertension, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-04-23.

Sponsored by University Ghent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arterial Hypertension

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Keywords

  • hypertension
  • sodium
  • diet
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 25 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    4-week diet, low in sodium

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

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

Interventions

  • OtherA 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.

06

What researchers measure

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

07

Study locations

1 site
  • University Ghent
    Ghent, 9000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01334138
Lead sponsor
University Ghent
Collaborators
Fund for Scientific Research, Flanders, Belgium
Responsible party
Sponsor
First posted
Apr 12, 2011
Start date
May 2010
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Apr 23, 2012

Study contacts

Stefaan Dehenauw, Ph.D, Professor
principal investigator · University Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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