CompletedNot Applicable

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

Netherlands40 participantsStarted 2012-01

Plain-language summary

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.

Who can participate

Age range

40 Years – 90 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: * (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 d…

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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 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.

Timeframe: 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)

Trial details

NCT IDNCT01575041

SponsorWageningen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07

View on ClinicalTrials.gov More Hypertension trials