Clinical trial NCT01575041: The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function
Official title: Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (pre)hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Vascular Function
Renal Function
Keywords: sodium
salt
potassium
blood pressure
flow-mediated dilatation
endothelial function
renal function
controlled feeding study
dietary intervention
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2012-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 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)
Secondary outcomes:
measure: Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
timeFrame: 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)
measure: 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.
timeFrame: 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)
measure: Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
timeFrame: 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)
measure: 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.
timeFrame: 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)
measure: Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
timeFrame: 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)
measure: 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.
timeFrame: 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)
measure: Liver function parameters
timeFrame: 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)
measure: 24-hour urinary mineral excretions
timeFrame: 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)
measure: 24-hour excretion of protein, albumin and creatinine
timeFrame: 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)
measure: Adverse events
timeFrame: Every day
measure: Anthropometric measurements
timeFrame: 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)
measure: Heart rate
timeFrame: 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)
measure: Food frequency questionnaire
timeFrame: Screening
measure: 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.
timeFrame: 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)
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University, Division of Human Nutrition
name: Johanna M Geleijnse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Humalda JK, Yeung SMH, Geleijnse JM, Gijsbers L, Riphagen IJ, Hoorn EJ, Rotmans JI, Vogt L, Navis G, Bakker SJL, de Borst MH. Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study. J Clin Endocrinol Metab. 2020 Sep 1;105(9):e3246-56. doi: 10.1210/clinem/dgaa359.