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Combined Dietary Education of Low Sodium and High Potassium Consumption

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01914224
Enrollment
200
Registered
2013-08-02
Start date
2013-03-31
Completion date
2014-12-31
Last updated
2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Prehypertension

Keywords

Prehypertension, Hypertension, Sodium, Potassium, renin, aldosterone

Brief summary

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.

Interventions

BEHAVIORALdietary education of low sodium and high potassium consumption
BEHAVIORALdietary education of low sodium consumption only

Sponsors

Ministry of Food and Drug Safety, Korea
CollaboratorOTHER_GOV
DongGuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Prehypertension: with a systolic pressure from 120 to 139 mm Hg or a diastolic pressure from 80 to 89 mm Hg 2. 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

1. Urinary tract disease 2. Secondary hypertension 3. Previous history of unstable angina, heart failure, myocardial infarction, coronary revascularization, cerebrovascular disease within 12 months 4. Ventricular tachycardia, atrial fibrillation and flutter 5. Hypertrophic cardiomyopathy 6. Known chronic kidney disease: serum creatinine = or \> 2.0 mg/dL 7. Hypokalemia (\<3.5 mmol/L) or hyperkalemia (\>5.5 mmol/L) 8. Type 1 diabetes mellitus 9. Poorly controlled diabetes mellitus (HbA1C = or \> 9%) 10. Unable to collect 24 hour urine sample 11. Pregnancy 12. Alcoholics 13. Severe liver disease 14. Night workers 15. Mental retardation

Design outcomes

Primary

MeasureTime frameDescription
changes of 24-hour ambulatory systolic and diastolic blood pressure3 monthsEffectiveness 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.

Secondary

MeasureTime frameDescription
changes of 24-hour urine sodium and potassium excretion3 monthsDifference of changes of 24-hour urine sodium and potassium excretion by each dietary education
changes of renin and aldosterone3 monthsDifference in changes of renin and aldosterone by each dietary education

Other

MeasureTime frameDescription
Changes of renin and aldosterone3 monthsChanges of renin and aldosterone by low sodium consumption
Changes of pulse wave velocity3 monthsChanges of pulse wave velocity by low sodium consumption
Changes of left ventricular mass index3 monthsChanges of left ventricular mass index by low sodium consumption

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026