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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Prehypertension
• Intervention / Treatment: Behavioral: dietary education of low sodium and high potassium consumption; Behavioral: dietary education of low sodium consumption only

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of, 410-773
      • Recruiting
      • DongGuk University ilsan Hospital
      • Contact: Moo-Yong Rhee, MD, PhD; Phone Number: 82 31 961 7125; Email: mooyong.rhee@gmail.com
      • Contact: Ji-Hyun Kim, MD, PhD; Phone Number: 82 31 961 7270; Email: mdangela79@gmail.com
      • Sub-Investigator: Ji-Hyun Kim, MD, PhD
      • Principal Investigator: Moo-Yong Rhee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; dietary education of low sodium and high potassium consumption	Behavioral: dietary education of low sodium and high potassium consumption
Active Comparator: Group 2; dietary education of low sodium consumption only	Behavioral: dietary education of low sodium consumption only

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of renin and aldosterone	Changes of renin and aldosterone by low sodium consumption	3 months
Changes of pulse wave velocity	Changes of pulse wave velocity by low sodium consumption	3 months
Changes of left ventricular mass index	Changes of left ventricular mass index by low sodium consumption	3 months

Collaborators and Investigators

• Sponsor: DongGuk University
• Collaborators: Ministry of Food and Drug Safety, Korea
• Investigators: Principal Investigator: Moo-Yong Rhee, MD, PhD, DongGuk University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Prehypertension; Hypertension; aldosterone; Sodium; Potassium; renin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: 13162MFDS106