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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01575041
Other study ID # KaNa-trial
Secondary ID
Status Completed
Phase N/A
First received March 20, 2012
Last updated August 9, 2012
Start date January 2012
Est. completion date August 2012

Study information

Verified date August 2012
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical 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.


Description:

This is a randomized, double-blind, placebo controlled cross-over feeding study.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 90 Years
Eligibility 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, ?-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 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Intervention

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
Placebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day.

Locations

Country Name City State
Netherlands Wageningen University Wageningen

Sponsors (2)

Lead Sponsor Collaborator
Wageningen University Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) No
Secondary 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)
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) No
Secondary 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
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) No
Secondary 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 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) No
Secondary 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-a, vWF, nitric oxide 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) No
Secondary 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) 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) No
Secondary 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) 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) No
Secondary Liver function parameters Montoring liver function parameters for safety: includes ALAT, ASAT and ?-GT 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) Yes
Secondary 24-hour urinary mineral excretions Sodium and potassium (as compliance markers) 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) No
Secondary 24-hour excretion of protein, albumin and creatinine In addition, protein is assessed in spot urine during screening using a dipstick test 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) Yes
Secondary Adverse events Patient diary for occasions of illness, hospitalizations, medication use and other information on potential side effects Every day Yes
Secondary Anthropometric measurements Body weight (weekly), height (only at baseline), waist circumference (baseline and every 4 weeks) 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) No
Secondary Heart rate Dinamap, 4 consecutive measurements with 2-min intervals 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) No
Secondary Food frequency questionnaire Screening No
Secondary 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) 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) No
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