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Korean Life-Style Modification Effects on Blood Pressure

This study is currently recruiting participants.
Verified July 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01637909
First received: July 8, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • changes of blood pressure after intervention [ Time Frame: after 1 week, 4weeks, 8weeks intervention for each group intervention ] [ Designated as safety issue: No ]
    The primary outcome will be the difference in sitting brachial systolic blood pressure after 8 weeks intervention. The study population was determined by treatment group 1 will have systolic BP lowering effect of 11.5mmHg with standard deviation of 10.0mmHg and group 2 will have systolic BP lowering effect of 18.0mmHg with standard deviation of 15.0mmHg. with statistical power of 80% and drop out rate of 25%, the number needed was determined to be 32 in the control group, 22 in group 1 and 22 in group 2.


Estimated Enrollment: 76
Study Start Date: September 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: general management Drug: Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.
All the study subjects will undergo baseline brachial blood pressure measurement(OMRON HEM 7080IT), central aortic blood pressure measurement with Sphygmocor device(AtCor Medical), baseline laboratory, 24hr urine Na measurement, 24 hour ambulatory blood pressure and cardiopulmonary exercise test. These tests will be repeated at the 8th week.
Experimental: The treatment group1
Korean DASH diet with sodium reduction intervention
 Dietary Supplement: Treatment group 1(Dietary intervention)
The dietary intervention is based on active education of the enrolled subjects based on Korean modified DASH diet. The enrolled subjects are advised to substitute processed white rice with whole grains such as barley. For protein, the subjects are advised to consume chicken and fish instead of red meat. Also, consumption of nuts are recommended where as processed foods containing high fructose corn syrup are not recommended. We will recommend to reduce salt intake by advising the subjects from adding table salts to their meals as well as adding salt during cooking. We will advise the subjects from eating pickles and condiments, which are the main source of salt in the Korean population. The degree of salt reduction before and after intervention will be assessed by 24 hour recall as well as measurement of 24 hour urine Na collection at baseline and at the 8th week. The compliance of the subjects will be assessed by 24hr recall as well.
Experimental: The treatment group2
Korean DASH diet with sodium reduction intervention and excersize intervention
 Other: Treatment group 2(dietary and exercise intervention)
The dietary intervention will be combined with exercise intervention. At baseline, the subjects will undergo evaluation for (1) cardiopulmonary function by undergoing cardiopulmonary exercise test and 3 minute step test 2) muscle strength assessment by hand grip test and 3) push ups to assess muscle endurance. After the initial evaluation, the subjects will be subjected to a course in aerobic exercise and muscle strengthening exercise developed by the Yonsei University Physical education department and will receive an educational DVD program. The subjects will each be given an electronic step counter to assess the degree of exercise. All the subjects in the treatment group 2 will be advised to undergo moderate to stenuous aerobic exercise for least 150 minutes /per week. Also, the subjects will be educated to perform muscle strengthening exercise as specificed in the educational program. The subjects will be asked to submit an exercise diary to assess the degree of compliance.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637909

Contacts
Contact: Sungha Park, MD 82-2-2228-8455 SHPARK0530@yuhs.ac.kr

Locations
Korea, Republic of
Yonsei universty medical center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sungha Park, Md            
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01637909     History of Changes
Other Study ID Numbers: 4-2011-0305
Study First Received: July 8, 2012
Last Updated: July 10, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Yonsei University:
Prehypertension, Hypertension

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013