Combined Dietary Education of Low Sodium and High Potassium Consumption

Study Overview
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Brief Summary
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Reduction in sodium consumption is important approach in public health care. In general population, reduction of sodium intake can reduce the future development of hypertension and cardiovascular event. Meanwhile, enhancement of potassium consumption is also important to reduce blood pressure and cardiovascular events. We hypothesized that combined education of low sodium and high potassium consumption is more effective in reducing blood pressure compared to dietary education of low sodium consumption only. The present survey study was designed to test the effectiveness of combined education of low sodium and high potassium consumption in blood pressure reduction and improvement of other variables.

Official Title
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Research for the Effectiveness of Combined Dietary Education of Low Sodium and High Potassium Consumption

Conditions
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Prehypertension, Hypertension

Intervention / Treatment
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* Behavioral: dietary education of low sodium and high potassium consumption
* Behavioral: dietary education of low sodium consumption only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prehypertension: with a systolic pressure from 120 to 139 mm Hg or a diastolic pressure from 80 to 89 mm Hg Stage 1 hypertension: with a systolic pressure from 140 to 159 mm Hg or a diastolic pressure from 90 to 99 mm Hg Exclusion Criteria: Urinary tract disease Secondary hypertension Previous history of unstable angina, heart failure, myocardial infarction, coronary revascularization, cerebrovascular disease within 12 months Ventricular tachycardia, atrial fibrillation and flutter Hypertrophic cardiomyopathy Known chronic kidney disease: serum creatinine = or > 2.0 mg/dL Hypokalemia (<3.5 mmol/L) or hyperkalemia (>5.5 mmol/L) Type 1 diabetes mellitus Poorly controlled diabetes mellitus (HbA1C = or > 9%) Unable to collect 24 hour urine sample Pregnancy Alcoholics Severe liver disease Night workers Mental retardation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>dietary education of low sodium and high potassium consumption | Behavioral: dietary education of low sodium and high potassium consumption<br> <br> |
| Active Comparator: Group 2<br>dietary education of low sodium consumption only | Behavioral: dietary education of low sodium consumption only<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of 24-hour ambulatory systolic and diastolic blood pressure | Effectiveness of combined dietary education of low sodium and high potassium consumption on changes of 24-hour ambulatory systolic and diastolic blood pressure, compared to dietary education of low sodium consumption only. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of 24-hour urine sodium and potassium excretion | Difference of changes of 24-hour urine sodium and potassium excretion by each dietary education | 3 months | 
| changes of renin and aldosterone | Difference in changes of renin and aldosterone by each dietary education | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehypertension, Hypertension, Sodium, Potassium, renin, aldosterone