HypertensionNCT03314727
Effects of Salt on Serum Osmolarity and Hemodynamics Parameters
A study testing High salt (NaCl) intake in people with Hypertension and Sodium Excess, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Sodium Excess, Oxidative Stress
- What is being tested?
- High salt (NaCl) intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, no smoker, no obese >30 BMI, no drug use in the previous month
Who cannot join
- Any systemic disease, no past history of any cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Salt and The Amount of Water Consumption Simultaneously On Serum Osmolarity and Their Effects on Hemodynamic Parameters and Inflammation
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.
Read more
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.
- Conditions
- Hypertension, Sodium Excess, Oxidative Stress, Inflammation
- Being tested
- High salt (NaCl) intake
- Keywords
- Osmolar Concentration, Oxidative Stress, Salt, Inflammation, Endothelial Function, Hypertension
- Medical subject headings
- Hypertension, Hypernatremia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High salt (NaCl) intakeOther
Participants are asked to consume two high sodium-containing soups while monitoring their serum osmolarity levels
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: High salt (NaCl) intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline systolic and diastolic blood pressure
Systolic and diastolic blood pressures are measured with an aneroid sphygmomanometer. Unit of measurement is mmHg.
Measured: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4
Secondary outcomes (5)
Serum osmolarity increase
2x[Na]+[Glucose]/18+[Blood Urea Nitrogen]/2.8
Measured: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4
Change from baseline blood copeptin levels
Blood concentration in pg/ml
Measured: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4
Change from baseline augmentation index
Augmentation index (AIx@75) is the difference between the second and the first peaks of the central aortic waveform expressed as the percentage (%) of the aortic pulse pressure. It is measured non invasively using Mobil Pulse Wave Analysis device from brachial artery. This outcome measure will be used for the assessment of arterial stiffness.
Measured: Baseline time 0, Hour 4
Change from baseline pulse wave velocity
Pulse wave velocity (PWV) is the travel time (m/s) of a pressure wave from common carotid to the brachial artery, as a measure of aortic compliance. It is measured non invasively using Mobil Pulse Wave Analysis device from brachial artery. This outcome measure will be used for the assessment of arterial stiffness.
Measured: Baseline time 0, Hour 4
Change from baseline flow mediated dilation
Endothelial function was measured via noninvasive ultrasound imaging. Participants were asked to lie supine for a 10-minute resting period where a three-lead ECG was placed for monitoring of heart rate and rhythm throughout the procedures. Standard ultrasonography equipment (Epiq 7, Philips Medical, and Bothell, WA) with a 12-megahertz linear array probe was used to obtain B-mode images of the left brachial artery approximately 2-10 cm proximal to the elbow. Following measurement of resting artery diameter, a blood pressure cuff was placed distally to the brachial artery (antecubital space) and inflated to a suprasystolic level (200 mm/Hg) for 5 minutes to induce ischemia. After the abrupt release of the cuff pressure, changes in blood flow and vessel diameter (FMD) over a 5-minute period were imaged.
Measured: Baseline time 0, Hour 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Kanbay, MD, Principal investigator, Koc University Sch. Med. Dept. Internal Med. Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314727
- Sponsor's protocol ID
- 2015.097.IRB2.037
- Status last verified
- Sep 2017
- First submitted
- 28 Sep 2017
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Salt and The Amount of Water Consumption Simultaneously On Serum Osmolarity and Their Effects on Hemodynamic Parameters and Inflammation
- ClinicalTrials.gov ID
- NCT03314727
- Acronym / sponsor ID
- 2015.097.IRB2.037
- Conditions
- Hypertension, Sodium Excess, Oxidative Stress, Inflammation
- Keywords
- Osmolar Concentration, Oxidative Stress, Salt, Inflammation, Endothelial Function, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Drink 200 ml soup with no added salt |
| High salt (NaCl) intake | Experimental | Other: High salt (NaCl) intakeGroup 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, no smoker, no obese >30 BMI, no drug use in the previous month
Key exclusion criteria (1 listed)
- Any systemic disease, no past history of any cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High salt (NaCl) intakeParticipants are asked to consume two high sodium-containing soups while monitoring their serum osmolarity levels | Other | High salt (NaCl) intake |
Primary outcome
Change from baseline systolic and diastolic blood pressure
Time frame: 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.
5 secondary outcomes
Serum osmolarity increase
Time frame: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4
Change from baseline blood copeptin levels
Time frame: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4
Change from baseline augmentation index
Time frame: Baseline time 0, Hour 4
Change from baseline pulse wave velocity
Time frame: Baseline time 0, Hour 4
Change from baseline flow mediated dilation
Time frame: Baseline time 0, Hour 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Kanbay, MD principal investigator
Koc University Sch. Med. Dept. Internal Med. Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High salt (NaCl) intake in people with Hypertension and Sodium Excess, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline systolic and diastolic blood pressure (time frame: Baseline time 0, Hour 1, Hour 2, Hour 3, Hour 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.