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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01334138
Other study ID # 2010/233
Secondary ID
Status Completed
Phase N/A
First received April 11, 2011
Last updated April 20, 2012
Start date May 2010
Est. completion date April 2011

Study information

Verified date April 2012
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Belgium University Ghent Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of blood pressure after a 4-week diet, low in sodium. after 4 weeks No
Secondary Life style change after a 4-week diet, low in sodium. after 4 weeks No
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