HypertensionKaNaNCT01575041
The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function
A study testing Sodium and Potassium in people with Hypertension and Blood Pressure, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure, Vascular Function
- What is being tested?
- Sodium and Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Aug 2012
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
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- 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.
Who cannot join
- 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;
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- 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 diet for 13 weeks;
- Problems with consuming the supplements or following the study guidelines;
- Unwilling to undergo home or office blood pressure measurements;
- Recent blood donation i.e. 1 month (male subjects) or 2 months (female subjects) prior to the study and planned donation during the study period;
- Reported intense sporting activities > 10 h/w;
- Not agreeing to be informed about unexpected and medically relevant personal test-results
- Participation in another biomedical trial less than 2 months before the start of the study or at the same time;
- No informed consent signed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (pre)hypertensive Subjects
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.
Read the detailed description
This is a randomized, double-blind, placebo controlled cross-over feeding study.
- Conditions
- Hypertension, Blood Pressure, Vascular Function, Renal Function
- Being tested
- Sodium, Potassium, Placebo
- Keywords
- sodium, salt, potassium, blood pressure, flow-mediated dilatation, endothelial function, renal function, controlled feeding study, dietary intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SodiumDietary supplement
Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
PotassiumDrug
Potassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams.
PlaceboDrug
Placebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day.
| Study group | Role | What they receive |
|---|---|---|
| Sodium | Active comparator | For 4 weeks subjects will consume 3 grams of sodium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet Receives: Dietary Supplement: Sodium |
| Potassium | Active comparator | For 4 weeks subjects will consume 3 grams of potassium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet. Receives: Dietary Supplement: Sodium; Drug: Potassium |
| Placebo | Placebo comparator | For 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet Receives: Dietary Supplement: Sodium; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Ultra-sonography (brachial artery) + Picus system
Measured: 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)
Secondary outcomes (14)
Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Includes:
Office BP (Dinamap, 4 consecutive measurements with 2-min intervals) ABPM (Spacelab; 1x24h, at baseline, week 5, week 9, week 13)
Measured: Screening. 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)
Change in Pulse Wave Velocity comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Device: SphygmoCor (tonometry)
Parameters: Pulse Wave Velocity and at baseline, week 5, week 9 and week 13
Measured: 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)
Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Device: PeriFlux 5000 (Perimed, Sweden0
Measured: 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)
Change in Biomarkers of endothelial function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Plasma analysis of endothelin-1, ADMA, MCP-1, sVCAM-1, sICAM-1, sE-selectin, sTM, CRP, SAA, IL-6, IL-8, TNF-α, vWF, nitric oxide
Measured: 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)
Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
eGFR, serum creatinine (at screening also used as safety parameter)
Measured: Screening. 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)
Change in cardiovascular parameters in plasma comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, insulin and glucose (at screening also used as safety parameter)
Measured: Screening. 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)
Liver function parameters
Montoring liver function parameters for safety: includes ALAT, ASAT and ɣ-GT
Measured: Screening. 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)
24-hour urinary mineral excretions
Sodium and potassium (as compliance markers)
Measured: Screening. 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)
24-hour excretion of protein, albumin and creatinine
In addition, protein is assessed in spot urine during screening using a dipstick test
Measured: Screening. 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)
Adverse events
Patient diary for occasions of illness, hospitalizations, medication use and other information on potential side effects
Measured: Every day
Anthropometric measurements
Body weight (weekly), height (only at baseline), waist circumference (baseline and every 4 weeks)
Measured: Screening. 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)
Heart rate
Dinamap, 4 consecutive measurements with 2-min intervals
Measured: Screening. 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)
Food frequency questionnaire
Measured: Screening
Change in Pulse Wave Analysis comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Device: SphygmoCor (tonometry)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Principal investigator, Marianne Geleijnse, Wageningen University
- Investigators
- Johanna M Geleijnse, PhD, Principal investigator, Wageningen University, Division of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575041
- Sponsor's protocol ID
- KaNa-trial
- Acronym
- KaNa
- Status last verified
- Aug 2012
- First submitted
- 20 Mar 2012
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Humalda JK, Yeung SMH, Geleijnse JM, Gijsbers L, Riphagen IJ, Hoorn EJ, Rotmans JI, Vogt L, Navis G, Bakker SJL, de Borst MH. Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study. J Clin Endocrinol Metab. 2020 Sep 1;105(9):e3246-56. doi: 10.1210/clinem/dgaa359.
PubMed 32506135
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (pre)hypertensive Subjects
- ClinicalTrials.gov ID
- NCT01575041
- Acronym / sponsor ID
- KaNa / KaNa-trial
- Conditions
- Hypertension, Blood Pressure, Vascular Function, Renal Function
- Keywords
- sodium, salt, potassium, blood pressure, flow-mediated dilatation, endothelial function, renal function, controlled feeding study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Apr 2012 (estimated)
- 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.
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.
Detailed description
This is a randomized, double-blind, placebo controlled cross-over feeding study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium | Active comparator | Dietary Supplement: SodiumFor 4 weeks subjects will consume 3 grams of sodium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet |
| Potassium | Active comparator | Dietary Supplement: Sodium, Drug: PotassiumFor 4 weeks subjects will consume 3 grams of potassium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet. |
| Placebo | Placebo comparator | Dietary Supplement: Sodium, Drug: PlaceboFor 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- (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:
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| SodiumSodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams. | Dietary supplement | Placebo, Potassium, Sodium |
| PotassiumPotassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams. | Drug | Potassium |
| PlaceboPlacebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day. | Drug | Placebo |
Primary outcome
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.
Time frame: 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)
Ultra-sonography (brachial artery) + Picus system
14 secondary outcomes
Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Time frame: Screening. 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)
Change in Pulse Wave Velocity comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Time frame: 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)
Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Time frame: 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)
Change in Biomarkers of endothelial function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Time frame: 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)
Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Time frame: Screening. 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)
Change in cardiovascular parameters in plasma comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Time frame: Screening. 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)
Liver function parameters
Time frame: Screening. 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)
24-hour urinary mineral excretions
Time frame: Screening. 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)
24-hour excretion of protein, albumin and creatinine
Time frame: Screening. 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)
Adverse events
Time frame: Every day
Anthropometric measurements
Time frame: Screening. 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)
Heart rate
Time frame: Screening. 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)
Food frequency questionnaire
Time frame: Screening
Change in Pulse Wave Analysis comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Time frame: 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)
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 1 Apr 2025.
- Derived from this study: PubMed 32506135Humalda JK, Yeung SMH, Geleijnse JM, Gijsbers L, Riphagen IJ, Hoorn EJ, Rotmans JI, Vogt L, Navis G, Bakker SJL, de Borst MH. Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study. J Clin Endocrinol Metab. 2020 Sep 1;105(9):e3246-56. doi: 10.1210/clinem/dgaa359.
- Website of the Top Institute Food and Nutrition, Wageningen, The NetherlandsLink provided by the sponsor.
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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.
Johanna M Geleijnse, PhD principal investigator
Wageningen University, Division of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium and Potassium in people with Hypertension and Blood Pressure, run by Wageningen University at 1 site in Netherlands.
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 10 inclusion and 19 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 1 Apr 2025. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 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. (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01575041, which also lists 1 linked publication.
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 1 Apr 2025.