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

NCT ID: NCT01575041

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Hypertension; Blood Pressure; Vascular Function; Renal Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Sodium

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

Group Type: ACTIVE_COMPARATOR

Sodium

Intervention Type: DIETARY_SUPPLEMENT

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

Potassium

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.

Group Type: ACTIVE_COMPARATOR

Sodium

Intervention Type: DIETARY_SUPPLEMENT

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

Potassium

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Sodium

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: DRUG

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

Interventions

Sodium

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

Intervention Type: DIETARY_SUPPLEMENT

Potassium

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Top Institute Food and Nutrition

OTHER

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Marianne Geleijnse

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johanna M Geleijnse, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University, Division of Human Nutrition

Locations

Wageningen University

Wageningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 32506135 (View on PubMed)

Related Links

http://www.tifn.nl

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

Other Identifiers

KaNa-trial

Identifier Type: -

Identifier Source: org_study_id