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

Hypertension Clinical Trial

— KaNa  

Official title:

Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (Pre)Hypertensive Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575041
• Other study ID #: KaNa-trial
• 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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension
• Renal Function
• Vascular Function

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

External Links

•   Website of Division of Human Nutrition, Wageningen University, The Netherlands
•   Website of the KaNa trial, in Dutch
•   Website of the Top Institute Food and Nutrition, Wageningen, The Netherlands