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

Information source: Wageningen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Blood Pressure; Vascular Function; Renal Function

Intervention: Sodium (Dietary Supplement); Potassium (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Wageningen University

Official(s) and/or principal investigator(s):
Johanna M Geleijnse, PhD, Principal Investigator, Affiliation: Wageningen University, Division of Human Nutrition

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.

Clinical Details

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

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

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.

Secondary outcome:

Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.

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.

Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.

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.

Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.

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.

Liver function parameters

24-hour urinary mineral excretions

24-hour excretion of protein, albumin and creatinine

Adverse events

Anthropometric measurements

Heart rate

Food frequency questionnaire

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.

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

Eligibility

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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 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.

Locations and Contacts

Wageningen University, Wageningen 6703 HD, Netherlands
Additional Information

Website of the KaNa trial, in Dutch

Website of Division of Human Nutrition, Wageningen University, The Netherlands

Website of the Top Institute Food and Nutrition, Wageningen, The Netherlands

Starting date: January 2012
Last updated: August 9, 2012

Page last updated: August 23, 2015

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