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临床试验/NCT03314727
NCT03314727已完成不适用

Effects of Salt and The Amount of Water Consumption Simultaneously On Serum Osmolarity and Their Effects on Hemodynamic Parameters and Inflammation

Koç University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Change from baseline systolic and diastolic blood pressure

研究概览

简要总结

Diets containing excessive salt (>12 g/day) have negative effects on kidney and cardiovascular system. Considering this known fact, the investigators aimed to study if the amount of the water taken with excessive salt had any part on these negative effects by testing the blood pressure, serum osmolality, endothelial functions, cardiac function, inflammatory parameters and sympathetic nervous system.

Excessive dietary salt raises the serum osmolality, which triggers the protection mechanisms of the body. The first mechanism is the secretion of vasopressin from posterior pituitary and the second one is the polyol mediated aldose reductase enzyme activation in renal tubules. In the beginning, water and a little amount of salt is reabsorbed from the kidneys for keeping the serum osmolality in normal ranges by the elevation of vasopressin. Besides the high levels of vasopressin for long durations may have a role in both developments of hypertension and the progression/development of chronic kidney disease. Polyol mediated aldose reductase enzyme turns glucose into sorbitol, which is turned to fructose by sorbitol dehydrogenase activity. Fructose is degraded by fructokinase activity into toxic substances. With this pathway, the acute energy need is satisfied, yet uric acid, local oxidative stress, and inflammatory mediators rise while nitric oxide levels decreasing. These facts are independent risk factors for both kidney disease progression and hypertension. In addition, excessive salt intake may elevate the transforming growth factor beta-1 (TGF-B1) levels, which activates the sympathetic system, inflammation, and endothelial dysfunction.

According to these data, the investigators speculate that if they increase the amount of water intake while eating the high salt diet they may decrease the toxic effect of salt with less increase in serum osmolarity. To test this hypothesis, by regulating the salt and water amount in healthy people's diets, the investigators aimed to evaluate the following these parameters; biochemical parameters that could affect the blood and urine osmolality, blood pressure, vascular endothelial functions with the non-invasive flow-mediated dilatation technique and arterial stiffness, systolic and diastolic functions of the heart by transthoracic echocardiography. In addition, it was planned to evaluate the hormonal effects of arginine vasopressin, a long peptide with 39 amino acids, which is longer and easier to measure than vasopressin levels in serum by measuring the pituitary hormone-derived copeptin.

Although, decreasing the salt intake is the first step of the treatment in hypertension, and kidney diseases, the compliance rate to less sodium intake is very low (<20%). The investigators aim is to evaluate the effects of water, which is taken acutely with the excessive salt intake on cardiovascular system and kidney. The findings of the study will important for public health. If the investigators prove their hypothesis, they may recommend increasing high water intake before feeling thirst of which may contribute to decreasing the prevalence of hypertension and kidney disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy, no smoker, no obese >30 BMI, no drug use in the previous month

排除标准

  • Any systemic disease, no past history of any cardiovascular disease

研究组 & 干预措施

Control group

No Intervention

Drink 200 ml soup with no added salt

High salt (NaCl) intake

Experimental

Group 2: Drink 200 ml soup with 3 g added salt Group 3: Drink 200 ml soup with 3 g added salt plus 500 ml water Group 4: Drink 200 ml soup with 3 g added salt plus 750 ml water

干预措施: High salt (NaCl) intake (Other)

结局指标

主要结局

Change from baseline systolic and diastolic blood pressure

时间窗: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4

Systolic and diastolic blood pressures are measured with an aneroid sphygmomanometer. Unit of measurement is mmHg.

次要结局

  • Change from baseline flow mediated dilation(Baseline time 0, Hour 4)
  • Change from baseline blood copeptin levels(Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4)
  • Change from baseline pulse wave velocity(Baseline time 0, Hour 4)
  • Serum osmolarity increase(Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4)
  • Change from baseline augmentation index(Baseline time 0, Hour 4)

研究者

发起方
Koç University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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