Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
NCT ID: NCT01724645
Last Updated: 2012-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2010-09-30
2011-02-28
Brief Summary
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To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.
To assess the controlling blood pressure and heart rate.
To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.
To evaluate the influence on Gamma-Glutamyl Transpeptidase.
To evaluate the influence on Cardiovascular risk factor.
To evaluate the influence on valsava score, breathing score and upright score.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
Korean traditional diets
The consumption of Korean traditional diets reflecting the characteristics of Korean traditional diets without the limitation of calories has an effect on control of cardiovascular risk factor, so this study instructed all subjects of the intervention group to consume about 2,100kcal of served meals freely.
The Korean Traditional diets, which encourages the intake of cooked rice, vegetables,soup,Kimchi and soy fermented foods.
Control group
Control group : told to "eat as usal diet) for 12weeks
Control group
Told to " eat as usal diets".
Interventions
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Korean traditional diets
The consumption of Korean traditional diets reflecting the characteristics of Korean traditional diets without the limitation of calories has an effect on control of cardiovascular risk factor, so this study instructed all subjects of the intervention group to consume about 2,100kcal of served meals freely.
The Korean Traditional diets, which encourages the intake of cooked rice, vegetables,soup,Kimchi and soy fermented foods.
Control group
Told to " eat as usal diets".
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject who have hypertension and type 2diabetes.
* Subject who have taking oral medications :
(hypoglycemic, blood pressure and lipid modifying drugs).
* Subject must provide written informed consent to participate in the study.
Exclusion Criteria
* Hypertension(DBP\>116mmHg or SBP\>200 mmHg) having the history of cardiovascular events or taking medications known to affect lipoprotein metabolism.
* Having Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (HbA1c \>9.0%).
* Subjects with the history of cancer.
* Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery.
* Having digestive, or central nervous system disorders.
* Subject is hematologic, or neuroretinopathy.
* Subject with uterine fibroids at ultrasonography.
* Having severe or malignant retinopathy.
* Having the impairment of renal and liver function, dysproteinemia, nephritic syndrome, or other renal disease.
* Having coagulopathy
* Having human immunodeficiency virus.
* Having the history of mental instability and of drug and alcohol.
* Having the history of reactions to our experimental products.
* Participating in other clinical trials within the past 2 months.
* Having laboratory tests, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study.
* Having the history of alcohol or substance abuse.
* Subject is pregnant, planning to become pregnant, or breast-feeding.
19 Years
80 Years
ALL
No
Sponsors
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Chonbuk National University Hospital
OTHER
Responsible Party
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Soo-Wan Chae
director
Principal Investigators
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Soo-Wan Chae, MD., PhD
Role: STUDY_DIRECTOR
Chonbuk National University Hospital
Locations
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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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CUH_KOREAN-FOOD_2-2_2010
Identifier Type: -
Identifier Source: org_study_id