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

NCT01575041 | Completed

• 1 other identifier: KaNa-trial
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (14)

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

  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)

• 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.

  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)

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

  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)

• 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.

  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)

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

  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)

Study Arms (3)

Sodium

ACTIVE COMPARATOR

For 4 weeks subjects will consume 3 grams of sodium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet

Dietary Supplement: Sodium

Potassium

ACTIVE COMPARATOR

For 4 weeks subjects will consume 3 grams of potassium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet.

Dietary Supplement: Sodium; Drug: Potassium

Placebo

PLACEBO COMPARATOR

For 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet

Dietary Supplement: Sodium; Drug: Placebo

Interventions

Sodium DIETARY_SUPPLEMENT

Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.

Placebo; Potassium; Sodium

Potassium DRUG

Potassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams.

Potassium

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Wageningen University: lead
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Wageningen University

Wageningen, 6703 HD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 32506135 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypertension

Interventions

Sodium; Potassium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Johanna M Geleijnse, PhD

  Wageningen University, Division of Human Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: April 10, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 1, 2025

Record last verified: 2012-08

Locations

NL (1)