Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes

Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.

This trial is being conducted to look for following changes when Korean traditional diets is taken in subjects with hypertension and type 2 diabetes:

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: Korean traditional diets; Dietary supplement: Control group

Detailed Description

The investigators aimed to investigate the efficacy of Korean traditional diets in controlling fasting blood glucose fluctuation, blood pressure, and cardiovascular risk factors in hypertensive and type 2 diabetic patients who were taking medications prescribed for respective diseases in a 12-week.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who are men and women volunteers 19~80years
• 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:

• Subject with a history or evidence of clinically significant gastrointestinal,anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor,psychiatric.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Korean traditional diets; Korean traditional diets (calorie 2,100kcal) for 12weeks	Dietary supplement: 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.; Other Names: The Korean Traditonal diets
Active Comparator: Control group; Control group : told to "eat as usal diet) for 12weeks	Dietary supplement: Control group; Told to " eat as usal diets".; Other Names: Control diets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1C :Glycated Hemoglobin	Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TG :Triglycerides	Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
TC :Total cholesterol	Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
HDL-C :High Density Lipoprotein-Cholesterol	HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
LDL-C : Low Density Lipoprotein-Cholesterol	LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Breathing score	Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Valsalva score	Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Upright score	Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.	84days
ApoA1 :Apolipoprotein A1	Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
ApoB :Apolipoprotein B	Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Apo E :Apolipoprotein E	Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Free fatty acid	Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Adiponectin	Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
PAI-1 :Plasminogen activator inhibitor type 1	PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Homocysteine	Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
FPG :Fasting plasma glucose	Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
DBP:Diastolic Blood Pressure	DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
SBP:Systolic Blood Pressure	SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Heart rate	Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
BMI:Body Mass Index	BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Body fat percent	Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Waist	Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.	84days
Obesity associated gut microbiome(Bacteriodetes)	Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Obesity associated gut microbiome(Firmicutes)	Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.	84days
Hypoglycemic(oral medication)	Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.	84days
Control blood pressure(oral medication)	Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.	84days
Lipid modifying (oral medication)	Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.	84days

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 12, 2012

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: November 9, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: diabetes; hypertension; Korean Traditional diets
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CUH_KOREAN-FOOD_2-2_2010