KaNa: The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized, double-blind, placebo controlled cross-over feeding study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sodium 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 |
Dietary Supplement: Sodium
Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
|
| Active Comparator: Potassium 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. |
Dietary Supplement: Sodium
Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
Drug: Potassium
Potassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams.
|
| Placebo Comparator: Placebo For 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet |
Dietary Supplement: Sodium
Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
Drug: Placebo
Placebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day.
|
Outcome Measures
Primary Outcome Measures
- 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. [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
Secondary Outcome Measures
- Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake. [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)]
Includes: Office BP (Dinamap, 4 consecutive measurements with 2-min intervals) ABPM (Spacelab; 1x24h, at baseline, week 5, week 9, week 13)
- 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. [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)]
Device: SphygmoCor (tonometry) Parameters: Pulse Wave Velocity and at baseline, week 5, week 9 and week 13
- Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake. [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)]
Device: PeriFlux 5000 (Perimed, Sweden0
- 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. [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)]
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
- Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake. [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)]
eGFR, serum creatinine (at screening also used as safety parameter)
- 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. [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)]
Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, insulin and glucose (at screening also used as safety parameter)
- Liver function parameters [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)]
Montoring liver function parameters for safety: includes ALAT, ASAT and ɣ-GT
- 24-hour urinary mineral excretions [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)]
Sodium and potassium (as compliance markers)
- 24-hour excretion of protein, albumin and creatinine [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)]
In addition, protein is assessed in spot urine during screening using a dipstick test
- Adverse events [Every day]
Patient diary for occasions of illness, hospitalizations, medication use and other information on potential side effects
- Anthropometric measurements [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)]
Body weight (weekly), height (only at baseline), waist circumference (baseline and every 4 weeks)
- Heart rate [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)]
Dinamap, 4 consecutive measurements with 2-min intervals
- Food frequency questionnaire [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. [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)]
Device: SphygmoCor (tonometry)
Eligibility Criteria
Criteria
Inclusion Criteria:
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(Pre)hypertension, defined as office SBP: 130-159 mmHg;
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No use of antihypertensive, lipid-lowering, anticoagulant or other cardiovascular medication;
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Age at start of the ≥ 40 years;
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Apparently healthy:
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No reported current or previous metabolic diseases
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No history of cardiovascular diseases
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No history of renal, liver or thyroid diseases
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No history of gastrointestinal diseases
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No diabetes mellitus
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Fasting laboratory parameters within normal range: renal function (serum creatinine, ureum), liver function (ALAT, ASAT, ɣ-GT) and serum glucose.
Exclusion Criteria:
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Body mass index > 40 kg/m²;
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Smoking
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Secondary hypertension;
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Weight loss or weight gain of 5 kg or more during the last 2 months;
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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.
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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
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Taking nutritional supplements and unwilling to discontinue;
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Women lactating, pregnant or intend to become pregnant during study;
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Reported dietary habits: medically prescribed diet, slimming diet;
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Reported alcohol consumption > 21 units/w (female subjects) or >28 units/w (male subjects);
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Unable or unwilling to consume one meal every workday at the university, or to consume the prescribed study diet for 13 weeks;
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Problems with consuming the supplements or following the study guidelines;
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Unwilling to undergo home or office blood pressure measurements;
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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;
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Reported intense sporting activities > 10 h/w;
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Not agreeing to be informed about unexpected and medically relevant personal test-results
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Participation in another biomedical trial less than 2 months before the start of the study or at the same time;
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No informed consent signed.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wageningen University | Wageningen | Netherlands | 6703 HD |
Sponsors and Collaborators
- Wageningen University
- Top Institute Food and Nutrition
Investigators
- Principal Investigator: Johanna M Geleijnse, PhD, Wageningen University, Division of Human Nutrition
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Website of Division of Human Nutrition, Wageningen University, The Netherlands
- Website of the Top Institute Food and Nutrition, Wageningen, The Netherlands
Publications
None provided.- KaNa-trial