CompletedNot Applicable

Effects of Salt on Serum Osmolarity and Hemodynamics Parameters

Turkey (Türkiye)10 participantsStarted 2017-09-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy, no smoker, no obese \>30 BMI, no drug use in the previous month Exclusion Criteria: * Any systemic disease, no past history of any cardiovascular disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focused on how salt intake affects blood pressure, oxidative stress, and inflammation — given my hypertension diagnosis, how does what they were measuring relate to my specific situation and what my treatment should look like?
2Since this trial has already been completed, has my doctor seen or reviewed any of its findings, and could those results influence the dietary or medication recommendations they're making for me?
3The study looked at something called serum osmolarity alongside blood pressure changes — can my doctor explain what that means in plain terms and whether my sodium levels or fluid balance are something we should be monitoring together?
4Reducing salt is often recommended for hypertension, but this trial was specifically studying how much salt actually shifts blood pressure readings — is there a target sodium intake my doctor thinks would make a meaningful difference for my blood pressure numbers?
5Before considering whether any research like this is relevant to me, are there standard, well-established treatments for my hypertension that my doctor thinks I should try first, and how would dietary changes like sodium reduction fit alongside any medications I might need?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline systolic and diastolic blood pressure

Timeframe: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4

Trial details

NCT IDNCT03314727

SponsorKoç University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-01

View on ClinicalTrials.gov More Hypertension trials