Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
9. november 2012 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
Jeollabuk-do
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Jeonju, Jeollabuk-do, Korea, Republikken, 560-822
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
|
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.
Andre navn:
|
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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".
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1C :Glycated Hemoglobin
Tidsramme: 84days
|
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TG :Triglycerides
Tidsramme: 84days
|
Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
TC :Total cholesterol
Tidsramme: 84days
|
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
Tidsramme: 84days
|
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
Tidsramme: 84days
|
LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
Breathing score
Tidsramme: 84days
|
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
|
Valsalva score
Tidsramme: 84days
|
Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
|
Upright score
Tidsramme: 84days
|
Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
|
84days
|
|
ApoA1 :Apolipoprotein A1
Tidsramme: 84days
|
Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
ApoB :Apolipoprotein B
Tidsramme: 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
Tidsramme: 84days
|
Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
Free fatty acid
Tidsramme: 84days
|
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
Adiponectin
Tidsramme: 84days
|
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
Tidsramme: 84days
|
PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
Homocysteine
Tidsramme: 84days
|
Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
FPG :Fasting plasma glucose
Tidsramme: 84days
|
Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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DBP:Diastolic Blood Pressure
Tidsramme: 84days
|
DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
SBP:Systolic Blood Pressure
Tidsramme: 84days
|
SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Heart rate
Tidsramme: 84days
|
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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weight
Tidsramme: 84days
|
weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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BMI:Body Mass Index
Tidsramme: 84days
|
BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
Body fat percent
Tidsramme: 84days
|
Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
|
Waist
Tidsramme: 84days
|
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)
Tidsramme: 84days
|
Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
|
Obesity associated gut microbiome(Firmicutes)
Tidsramme: 84days
|
Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
|
84days
|
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Hypoglycemic(oral medication)
Tidsramme: 84days
|
Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
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Control blood pressure(oral medication)
Tidsramme: 84days
|
Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
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Lipid modifying (oral medication)
Tidsramme: 84days
|
Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2010
Primær fullføring (Faktiske)
1. januar 2011
Studiet fullført (Faktiske)
1. februar 2011
Datoer for studieregistrering
Først innsendt
29. oktober 2012
Først innsendt som oppfylte QC-kriteriene
9. november 2012
Først lagt ut (Anslag)
12. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. november 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. november 2012
Sist bekreftet
1. november 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CUH_KOREAN-FOOD_2-2_2010
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