跳至主要内容
临床试验/NCT01334138
NCT01334138已完成不适用

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

University Ghent2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Measurement of blood pressure after a 4-week diet, low in sodium.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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...)

排除标准

  • 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

结局指标

主要结局

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

时间窗: after 4 weeks

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验