Korean Life-Style Modification Effects on Blood Pressure

Yonsei University

Status: Completed

Conditions: Hypertension; Prehypertension

Treatments: Dietary Supplement: Treatment group 1(Dietary intervention); Other: Treatment group 2(dietary and exercise intervention); Drug: Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.

Study type: Interventional

Funder types: Other

Identifiers

NCT01637909

4-2011-0305

Details and patient eligibility

About

In hypertension, lifestyle modification has been proven to be effective in reducing blood pressure while decreasing the risk of cardiovascular disease. The dietary approaches to stop hypertension(DASH) diet, sodium restriction and exercise has been shown to reduce systolic blood pressure by 8-14mmHg, 2-8mmHg and 4-9mmHg, respectively. The DASH-sodium diet has been shown to have additional systolic blood pressure lowering effect of 7.2mmHg, which is equal to adding one antihypertensive drug. However, as the dietary pattern is different in the Korean population, the investigators cannot implement the data from Western countries directly to the Korean population. For example, the consumption of dairy products is much smaller in the Korean population when compared to the western population. Therefore, the effectiveness of DASH-sodium diet and exercise on blood pressure lowering in the Korean population is not well defined. In this study, the investigators sought to determine the effectiveness of the DASH-salt diet and DASH-salt diet plus exercise on brachial blood pressure lowering. The study will be performed on untreated prehypertension patients and uncontrolled hypertensive patients undergoing anti hypertensive treatment with blood pressure measured between 140-159mmHg/90-99mmHg at the time of enrollment.

Enrollment: 85 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult age >20

2. If the subject not taken antihypertension, SBP and DBP must be the following result.

   SBP: 120~159 mmHg , DBP: 80-99 mmHg

3. If the subject taken antihypertension, SBP and DBP must be the following result.

   SBP: 140-159mmHg ,DBP: 90-99 mmHg

4. BMI 18.5kg/m²~44kg/m²

5. Patients voluntarily agreed to participate in this study

6. Non-pregnant women, Non-breastfeeding women, women of childbearing age must be negative in HCG result.

(not taking an oral contraceptive)

Exclusion criteria

1. If the subject not taken antihypertension, SBP and DBP must be the following result.

   • 120>SBP>159 mmHg, 80>DBP>99 mmHg

2. If the subject taken antihypertension, the number of three or more antihypertensive

3. If the subject taken antihypertension, SBP and DBP must be the following result.

   • 140>SBP>159 mmHg, 90>DBP>99 mmHg

4. having the target organ disease, the following disease.

   • Heart disease: Lt.venricular hyperplasia, Angina, MI, Coronary revascularization, Heart failure
   • Brain disease: Stroke, TIA, Dementia
   • Kidney disease:
   • Pheripheral artery disease
   • Retinopathy Disease

5. Cancer, Liver disease

6. Regular drinking alcohol above 14 cup of during 1 week.

7. Pregnant women, Women of childbearing age tested positive in HCG result.

8. Pregnant women, Breastfeeding women

9. screening test result CS

10. illiteracy, a foreigner, the person who can't read the consent

11. the person who had participated other study in 3 months.

12. the person who inappropriate to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 3 patient groups

general management

Active Comparator group

Treatment:

Drug: Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.

The treatment group1

Experimental group

Description:

Korean DASH diet with sodium reduction intervention

Treatment:

Dietary Supplement: Treatment group 1(Dietary intervention)

The treatment group2

Experimental group

Description:

Korean DASH diet with sodium reduction intervention and excersize intervention

Treatment:

Other: Treatment group 2(dietary and exercise intervention)