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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean traditional diets | Experimental | Korean traditional diets (calorie 2,100kcal) for 12weeks |
|
| Control group | Active Comparator | Control group : told to "eat as usal diet) for 12weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
Inclusion Criteria:
(hypoglycemic, blood pressure and lipid modifying drugs).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-Wan Chae, MD., PhD | Chonbuk National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2012 | |
| Reset | Dec 13, 2012 | |
| Release | Jul 29, 2013 | |
| Reset | Sep 26, 2013 | |
| Release | Aug 28, 2019 | |
| Reset | Sep 26, 2019 | |
| Release | Sep 27, 2019 | |
| Reset | Oct 18, 2019 | |
| Release | Oct 22, 2019 | |
| Reset | Nov 8, 2019 | |
| Release | Dec 17, 2019 | |
| Reset | Jan 3, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2012 | Dec 13, 2012 | |||
| Jul 29, 2013 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
|
| Control group | Dietary Supplement | Told to " eat as usal diets". |
|
|
| 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 |
| 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 |
| Sep 26, 2013 |
| Aug 28, 2019 | Sep 26, 2019 |
| Sep 27, 2019 | Oct 18, 2019 |
| Oct 22, 2019 | Nov 8, 2019 |
| Dec 17, 2019 | Jan 3, 2020 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008722 | Methods |