Hypertension Clinical Trial
— KaNaOfficial title:
Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (Pre)Hypertensive Subjects
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 90 Years |
Eligibility |
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, ?-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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University | Wageningen |
Lead Sponsor | Collaborator |
---|---|
Wageningen University | Top Institute Food and Nutrition |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake. | Includes: Office BP (Dinamap, 4 consecutive measurements with 2-min intervals) ABPM (Spacelab; 1x24h, at baseline, week 5, week 9, week 13) |
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) | No |
Secondary | 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. | Device: SphygmoCor (tonometry) Parameters: Pulse Wave Velocity and at baseline, week 5, week 9 and week 13 |
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) | No |
Secondary | Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake. | Device: PeriFlux 5000 (Perimed, Sweden0 | 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) | No |
Secondary | 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. | Plasma analysis of endothelin-1, ADMA, MCP-1, sVCAM-1, sICAM-1, sE-selectin, sTM, CRP, SAA, IL-6, IL-8, TNF-a, vWF, nitric oxide | 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) | No |
Secondary | Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake. | eGFR, serum creatinine (at screening also used as safety parameter) | 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) | No |
Secondary | 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. | Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, insulin and glucose (at screening also used as safety parameter) | 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) | No |
Secondary | Liver function parameters | Montoring liver function parameters for safety: includes ALAT, ASAT and ?-GT | 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) | Yes |
Secondary | 24-hour urinary mineral excretions | Sodium and potassium (as compliance markers) | 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) | No |
Secondary | 24-hour excretion of protein, albumin and creatinine | In addition, protein is assessed in spot urine during screening using a dipstick test | 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) | Yes |
Secondary | Adverse events | Patient diary for occasions of illness, hospitalizations, medication use and other information on potential side effects | Every day | Yes |
Secondary | Anthropometric measurements | Body weight (weekly), height (only at baseline), waist circumference (baseline and every 4 weeks) | 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) | No |
Secondary | Heart rate | Dinamap, 4 consecutive measurements with 2-min intervals | 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) | No |
Secondary | Food frequency questionnaire | Screening | No | |
Secondary | 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. | Device: SphygmoCor (tonometry) | 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) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |