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
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