NCT01575041已完成不适用
Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (pre)hypertensive Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Endothelium-dependent flow-mediated dilation comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
研究概览
简要总结
To determine the effect of (1) increased sodium intake and (2) increased potassium intake on blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.
详细描述
This is a randomized, double-blind, placebo controlled cross-over feeding study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Pre)hypertension, defined as office SBP: 130-159 mmHg;
- •No use of antihypertensive, lipid-lowering, anticoagulant or other cardiovascular medication;
- •Age at start of the ≥ 40 years;
- •Apparently healthy:
- •No reported current or previous metabolic diseases
- •No history of cardiovascular diseases
- •No history of renal, liver or thyroid diseases
- •No history of gastrointestinal diseases
- •No diabetes mellitus
- •Fasting laboratory parameters within normal range: renal function (serum creatinine, ureum), liver function (ALAT, ASAT, ɣ-GT) and serum glucose.
排除标准
- •Body mass index > 40 kg/m²;
- •Secondary hypertension;
- •Weight loss or weight gain of 5 kg or more during the last 2 months;
- •Usage of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study.
- •Medical treatment that may affect blood pressure and not able (or willing) to stop taking them;
- •Women taking oral contraceptives or estrogen replacement therapy
- •Taking nutritional supplements and unwilling to discontinue;
- •Women lactating, pregnant or intend to become pregnant during study;
- •Reported dietary habits: medically prescribed diet, slimming diet;
- •Reported alcohol consumption > 21 units/w (female subjects) or >28 units/w (male subjects);
- •Unable or unwilling to consume one meal every workday at the university, or to consume the prescribed study diet for 13 weeks;
- •Problems with consuming the supplements or following the study guidelines;
- •Unwilling to undergo home or office blood pressure measurements;
- •Recent blood donation i.e. 1 month (male subjects) or 2 months (female subjects) prior to the study and planned donation during the study period;
- •Reported intense sporting activities > 10 h/w;
- •Not agreeing to be informed about unexpected and medically relevant personal test-results
- •Participation in another biomedical trial less than 2 months before the start of the study or at the same time;
- •No informed consent signed.
研究组 & 干预措施
Sodium
Active Comparator
For 4 weeks subjects will consume 3 grams of sodium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet
干预措施: Sodium (Dietary Supplement)
Potassium
Active Comparator
For 4 weeks subjects will consume 3 grams of potassium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet.
干预措施: Sodium (Dietary Supplement)
Potassium
Active Comparator
For 4 weeks subjects will consume 3 grams of potassium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet.
干预措施: Potassium (Drug)
Placebo
Placebo Comparator
For 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet
干预措施: Sodium (Dietary Supplement)
Placebo
Placebo Comparator
For 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Endothelium-dependent flow-mediated dilation comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
时间窗: Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Ultra-sonography (brachial artery) + Picus system
次要结局
- Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Change in Pulse Wave Velocity comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.(Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.(Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Change in Biomarkers of endothelial function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.(Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Change in cardiovascular parameters in plasma comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Liver function parameters(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- 24-hour urinary mineral excretions(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- 24-hour excretion of protein, albumin and creatinine(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Adverse events(Every day)
- Anthropometric measurements(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Heart rate(Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
- Food frequency questionnaire(Screening)
- Change in Pulse Wave Analysis comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.(Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3))
研究者
Marianne Geleijnse
Dr.
Wageningen University
研究点 (1)
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