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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01724645
First received: October 29, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Dietary Supplement: Korean traditional diets
Dietary Supplement: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • HbA1C :Glycated Hemoglobin [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.


Secondary Outcome Measures:
  • TG :Triglycerides [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • TC :Total cholesterol [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • HDL-C :High Density Lipoprotein-Cholesterol [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • LDL-C : Low Density Lipoprotein-Cholesterol [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Breathing score [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.

  • Valsalva score [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.

  • Upright score [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.

  • ApoA1 :Apolipoprotein A1 [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • ApoB :Apolipoprotein B [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Apo E :Apolipoprotein E [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Free fatty acid [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Adiponectin [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • PAI-1 :Plasminogen activator inhibitor type 1 [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Homocysteine [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • FPG :Fasting plasma glucose [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • DBP:Diastolic Blood Pressure [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • SBP:Systolic Blood Pressure [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Heart rate [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.


Other Outcome Measures:
  • weight [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • BMI:Body Mass Index [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Body fat percent [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Waist [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  • Obesity associated gut microbiome(Bacteriodetes) [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.

  • Obesity associated gut microbiome(Firmicutes) [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.

  • Hypoglycemic(oral medication) [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.

  • Control blood pressure(oral medication) [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.

  • Lipid modifying (oral medication) [ Time Frame: 84days ] [ Designated as safety issue: Yes ]
    Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.


Enrollment: 48
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Control diets

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724645

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Study Director: Soo-Wan Chae, MD., PhD Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Soo-Wan Chae, director, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01724645     History of Changes
Other Study ID Numbers: CUH_KOREAN-FOOD_2-2_2010
Study First Received: October 29, 2012
Last Updated: November 9, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Korean Traditional diets
hypertension
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014