Effects of Sodium Chloride or Its Substitute Salt Potassium Chloride on Vascular Function and Immune Response - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on retinal vessel diameter and the flicker-light-induced retinal vessel dilatation.
研究概览
简要总结
This is a prospective, monocentric, randomized trial to investigate how sodium chloride or its substitute potassium chloride acutely affects vascular function by ingestion via a salted soup. Furthermore we want to get insights on the pathophysiology by analyzing metabolism and cell function in relation to vascular reaction.
详细描述
Some of the leading death causes in western countries are attributed to artheriosclerosis with its consequences especially cardiovascular events. Beside lifestyle risk factors such as physical inactivity, adipositas and stress, high dietary sodium intake is one of the easiest modifiable factors to reduce development and progession of artheriosclerosis. Unfortunately high sodium diet is one of the hallmarks of western diet. Epidemiologic and experimental data have provided compelling evidence that high salt and its induced elevation in bloodpressure is an important factor in the development and progression of cardiovascular disease, artheriosclerosis with its endorgan failure.
To analyze the reasons for the hazardous effects of high oral sodium chloride exposure on vascular damage and a possible protective mechanism by the salt substitute potassium chloride, we intend to conduct a single-center randomized trial (ESCAPE-SALT). We aim to measure vascular function by flow mediated dilation (FMD) and dynamic vessel analysis (DVA) of retinal mircocirculation. Participants will be divided into 3 groups. Each group will be served a soup with different salt content. The salt composition is as follows: soup A (9 g sodium chloride), soup B (6 g sodium chloride plus 3 g potassium chloride), and soup C (6 g sodium chloride). The effects on blood pressure, body composition markers, electrolytes, inflammatory and metabolic response, and vascular function are measured before, 4 and 24 h after ingestion of the soup. Furthermore we will investigate the underlying mechanism by performing metabolomic, transcriptomic and proteomic anyalysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •full-aged
- •signed informed consent
- •no dietary restrictions
- •access to retina for microvascular measurement
排除标准
- •age <18 y
- •no retinal access for microvascular measurement
- •known glaucoma
- •antibiotic therapy within the last 4 weeks
- •immunosuppressive Therapie within the last 4 weeks (e.g. glucocorticoids)
- •s.p. malignancy
- •unknown fever within the last 4 weeks
- •salt wasting syndroms (e.g. renal tubular acidosis, Diabetes insipidus)
- •chronic kidney disease stage 4-5
- •known electrolyte disorder (e.g. hyperkalaemia, hypokalaemia, hypernatriaemia, hyponatriaema)
- •no or rejected informed consent
结局指标
主要结局
Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on retinal vessel diameter and the flicker-light-induced retinal vessel dilatation.
时间窗: Baseline, 4 hours, 24 hours
Flicker-induced dilatation and diameter of fundus vessels will be measured via funduscopy in a static an dynamic analysis before, 4 hours and 24 hours after ingestion of a salty soup and the change between the timepoints will be analyzed. First the diameter of venoles and arterioles in µm and their ratio are measured in a standardized fundus picture. In a second step we will film the fundus during three flicker-light periods of 20 seconds and measure the dilatation in percent during the flicker period.
Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on hypoxia-induced dilatation of brachial artery.
时间窗: Baseline, 4 hours, 24 hours
Flow mediated dilatation (FMD) as a marker for macrovascular function will be measured at baseline, 4 hours and 24 hours after ingestion of a salty soup. We will measure FMD by ultrasound based measurement of brachial artery diameter in mm before and after induced hypoxia for 5 minutes. The change of dilatation in percentage between the different timepoints will be analyzed.
次要结局
- Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on mitochondrial respiration capacity in PBMC.(Baseline, 4 hours, 24 hours)
- Effect of a single oral high-sodium chloride load or a partial substitution by potassium chloride on NO metabolism in serum and red blood cells.(Baseline, 4 hours, 24 hours)
- Effect of a single oral high-sodium chloride load or a partial substitution by potassium on metabolic profile in PBMC and plasma.(Baseline, 4 hours, 24 hours)
- Effect of a single oral high-sodium chloride load or a partial substitution by potassium on systemic inflammation markers.(Baseline, 4 hours, 24 hours)
研究者
Prof. Dr. med. Johannes Stegbauer
Assistant Professor
Heinrich-Heine University, Duesseldorf