Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
9 november 2012 uppdaterad av: Soo-Wan Chae, Chonbuk National University Hospital
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Jeollabuk-do
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Jeonju, Jeollabuk-do, Korea, Republiken av, 560-822
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
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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.
Andra namn:
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Aktiv komparator: Control group
Control group : told to "eat as usal diet) for 12weeks
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Told to " eat as usal diets".
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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HbA1C :Glycated Hemoglobin
Tidsram: 84days
|
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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TG :Triglycerides
Tidsram: 84days
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Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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TC :Total cholesterol
Tidsram: 84days
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Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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HDL-C :High Density Lipoprotein-Cholesterol
Tidsram: 84days
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HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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LDL-C : Low Density Lipoprotein-Cholesterol
Tidsram: 84days
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LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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Breathing score
Tidsram: 84days
|
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
|
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Valsalva score
Tidsram: 84days
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Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
|
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Upright score
Tidsram: 84days
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Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
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84days
|
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ApoA1 :Apolipoprotein A1
Tidsram: 84days
|
Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
|
ApoB :Apolipoprotein B
Tidsram: 84days
|
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
Tidsram: 84days
|
Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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Free fatty acid
Tidsram: 84days
|
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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Adiponectin
Tidsram: 84days
|
Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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PAI-1 :Plasminogen activator inhibitor type 1
Tidsram: 84days
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PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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Homocysteine
Tidsram: 84days
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Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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FPG :Fasting plasma glucose
Tidsram: 84days
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Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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DBP:Diastolic Blood Pressure
Tidsram: 84days
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DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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SBP:Systolic Blood Pressure
Tidsram: 84days
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SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Heart rate
Tidsram: 84days
|
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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weight
Tidsram: 84days
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weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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BMI:Body Mass Index
Tidsram: 84days
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BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
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Body fat percent
Tidsram: 84days
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Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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Waist
Tidsram: 84days
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Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
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84days
|
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Obesity associated gut microbiome(Bacteriodetes)
Tidsram: 84days
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Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
|
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Obesity associated gut microbiome(Firmicutes)
Tidsram: 84days
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Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
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84days
|
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Hypoglycemic(oral medication)
Tidsram: 84days
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Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
|
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Control blood pressure(oral medication)
Tidsram: 84days
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Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
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84days
|
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Lipid modifying (oral medication)
Tidsram: 84days
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Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2010
Primärt slutförande (Faktisk)
1 januari 2011
Avslutad studie (Faktisk)
1 februari 2011
Studieregistreringsdatum
Först inskickad
29 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
9 november 2012
Första postat (Uppskatta)
12 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 november 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 november 2012
Senast verifierad
1 november 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CUH_KOREAN-FOOD_2-2_2010
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