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Completed

NCT Number: NCT01724645

Beneficial Effects of Korean Traditional Diets 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Korean traditional diets

Dietary Supplement

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

Control group

Dietary Supplement

Told to " eat as usal diets".

Other names: Control diets

Primary outcomes

  1. HbA1C :Glycated Hemoglobin

    Time frame: 84days

    Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

Secondary outcomes

  1. TG :Triglycerides

    Time frame: 84days

    Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  2. TC :Total cholesterol

    Time frame: 84days

    Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  3. HDL-C :High Density Lipoprotein-Cholesterol

    Time frame: 84days

    HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  4. LDL-C : Low Density Lipoprotein-Cholesterol

    Time frame: 84days

    LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  5. Breathing score

    Time frame: 84days

    Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.

  6. Valsalva score

    Time frame: 84days

    Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.

  7. Upright score

    Time frame: 84days

    Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.

  8. ApoA1 :Apolipoprotein A1

    Time frame: 84days

    Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  9. ApoB :Apolipoprotein B

    Time frame: 84days

    Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  10. Apo E :Apolipoprotein E

    Time frame: 84days

    Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  11. Free fatty acid

    Time frame: 84days

    Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  12. Adiponectin

    Time frame: 84days

    Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  13. PAI-1 :Plasminogen activator inhibitor type 1

    Time frame: 84days

    PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  14. Homocysteine

    Time frame: 84days

    Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  15. FPG :Fasting plasma glucose

    Time frame: 84days

    Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  16. DBP:Diastolic Blood Pressure

    Time frame: 84days

    DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  17. SBP:Systolic Blood Pressure

    Time frame: 84days

    SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  18. Heart rate

    Time frame: 84days

    Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

Other outcomes

  1. weight

    Time frame: 84days

    weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  2. BMI:Body Mass Index

    Time frame: 84days

    BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  3. Body fat percent

    Time frame: 84days

    Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  4. Waist

    Time frame: 84days

    Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  5. Obesity associated gut microbiome(Bacteriodetes)

    Time frame: 84days

    Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.

  6. Obesity associated gut microbiome(Firmicutes)

    Time frame: 84days

    Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.

  7. Hypoglycemic(oral medication)

    Time frame: 84days

    Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.

  8. Control blood pressure(oral medication)

    Time frame: 84days

    Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.

  9. Lipid modifying (oral medication)

    Time frame: 84days

    Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 12, 2012
Registry last updated
Nov 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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