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The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function (KaNa)

2012年8月9日更新者：Wageningen University

Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (Pre)Hypertensive Subjects

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a randomized, double-blind, placebo controlled cross-over feeding study.

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

荷兰
- - Wageningen、荷兰、6703 HD
    - Wageningen University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

(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.

Exclusion Criteria:

Body mass index > 40 kg/m²;
Smoking
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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：基础科学
分配：随机化
介入模型：交叉作业
屏蔽：三倍

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Sodium 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	膳食补充剂：Sodium Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
有源比较器：Potassium 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.	膳食补充剂：Sodium Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams. 药品：Potassium Potassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams.
安慰剂比较：Placebo For 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet	膳食补充剂：Sodium Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams. 药品：Placebo Placebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
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. 大体时间：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	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)

次要结果测量

结果测量	措施说明	大体时间
Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake. 大体时间：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)	Includes: Office BP (Dinamap, 4 consecutive measurements with 2-min intervals) ABPM (Spacelab; 1x24h, at baseline, week 5, week 9, week 13)	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. 大体时间：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)	Device: SphygmoCor (tonometry) Parameters: Pulse Wave Velocity and at baseline, week 5, week 9 and week 13	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. 大体时间：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)	Device: PeriFlux 5000 (Perimed, Sweden0	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. 大体时间：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)	Plasma analysis of endothelin-1, ADMA, MCP-1, sVCAM-1, sICAM-1, sE-selectin, sTM, CRP, SAA, IL-6, IL-8, TNF-α, vWF, nitric oxide	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. 大体时间：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)	eGFR, serum creatinine (at screening also used as safety parameter)	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. 大体时间：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)	Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, insulin and glucose (at screening also used as safety parameter)	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 大体时间：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)	Montoring liver function parameters for safety: includes ALAT, ASAT and ɣ-GT	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 大体时间：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)	Sodium and potassium (as compliance markers)	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 大体时间：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)	In addition, protein is assessed in spot urine during screening using a dipstick test	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 大体时间：Every day	Patient diary for occasions of illness, hospitalizations, medication use and other information on potential side effects	Every day
Anthropometric measurements 大体时间：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)	Body weight (weekly), height (only at baseline), waist circumference (baseline and every 4 weeks)	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 大体时间：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)	Dinamap, 4 consecutive measurements with 2-min intervals	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 大体时间：Screening		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. 大体时间：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)	Device: SphygmoCor (tonometry)	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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Wageningen University

合作者

Top Institute Food and Nutrition

调查人员

首席研究员：Johanna M Geleijnse, PhD、Wageningen University, Division of Human Nutrition

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Humalda JK, Yeung SMH, Geleijnse JM, Gijsbers L, Riphagen IJ, Hoorn EJ, Rotmans JI, Vogt L, Navis G, Bakker SJL, de Borst MH. Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study. J Clin Endocrinol Metab. 2020 Sep 1;105(9):e3246-56. doi: 10.1210/clinem/dgaa359.

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年1月1日

初级完成 (实际的)

2012年7月1日

研究完成 (实际的)

2012年8月1日

研究注册日期

首次提交

2012年3月20日

首先提交符合 QC 标准的

2012年4月9日

首次发布 (估计)

2012年4月10日

研究记录更新

最后更新发布 (估计)

2012年8月10日

上次提交的符合 QC 标准的更新

2012年8月9日

最后验证

2012年8月1日

Sodium的临床试验

Lütfiye Nuri Burat Government Hospital

未知

IONM 对在甲状腺手术中使用 Sugammadex 的疗效和安全性的影响

声带麻痹 | 喉返神经

火鸡
Genta Incorporated

完全的

G3139 皮下注射实体瘤的 I 期研究

肿瘤

美国
Modus Therapeutics AB
University of Oxford

终止

Sevuparin/DF02 作为无并发症恶性疟疾患者的辅助疗法

疟疾、恶性疟

泰国
National Cheng-Kung University Hospital

招聘中

心脏手术中在胸骨边缘外用万古霉素

胸骨伤口感染

台湾
University of Alberta

完全的

18F-氟化钠 (18F-NaF) PET-CT 成像识别糖尿病患者的易损斑块 (D-NaF)

动脉粥样硬化 | 糖尿病并发症

加拿大
Sanofi

完全的

与安慰剂相比，AVE5026 对接受髋部骨折手术的患者静脉血栓栓塞的延长预防的评价 (SAVE-HIP3)

静脉血栓栓塞症

美国, 加拿大, 俄罗斯联邦, 乌克兰, 火鸡, 印度, 墨西哥, 埃及, 立陶宛, 哥伦比亚, 秘鲁, 大韩民国, 智利, 白俄罗斯, 中国, 南非
Sandoz

完全的

To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions

癫痫 | 躁郁症
Sandoz

完全的

证明双丙戊酸钠 500 mg 缓释片在禁食条件下的相对生物利用度

癫痫 | 躁郁症
Roswell Park Cancer Institute
National Cancer Institute (NCI)

招聘中

卟啉钠间质光动力疗法联合或不联合标准化疗治疗局部晚期或复发性头颈癌患者

复发性头颈癌 | 局部晚期头颈癌

美国
Cady, Roger, M.D.
GlaxoSmithKline

完全的

使用 Treximet™ 治疗偏头痛后的“完全反应”

偏头痛

美国

The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function (KaNa)

Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (Pre)Hypertensive Subjects

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

合作者

调查人员

出版物和有用的链接

一般刊物

有用的网址

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (估计)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

Sodium的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Suriname

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点