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

9 novembre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea, Repubblica di
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Corea, Repubblica di, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 19 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
Integratore alimentare: 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.

Altri nomi:
  • The Korean Traditonal diets
Comparatore attivo: Control group
Control group : told to "eat as usal diet) for 12weeks
Integratore alimentare: Control group
Told to " eat as usal diets".
Altri nomi:
  • Control diets

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
HbA1C :Glycated Hemoglobin
Lasso di tempo: 84days
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
TG :Triglycerides
Lasso di tempo: 84days
Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
TC :Total cholesterol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 84days
LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Breathing score
Lasso di tempo: 84days
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Valsalva score
Lasso di tempo: 84days
Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Upright score
Lasso di tempo: 84days
Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
84days
ApoA1 :Apolipoprotein A1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 84days
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Adiponectin
Lasso di tempo: 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
Lasso di tempo: 84days
PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Homocysteine
Lasso di tempo: 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
Lasso di tempo: 84days
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
Lasso di tempo: 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
Lasso di tempo: 84days
SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Heart rate
Lasso di tempo: 84days
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
weight
Lasso di tempo: 84days
weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
BMI:Body Mass Index
Lasso di tempo: 84days
BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Body fat percent
Lasso di tempo: 84days
Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Waist
Lasso di tempo: 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)
Lasso di tempo: 84days
Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Obesity associated gut microbiome(Firmicutes)
Lasso di tempo: 84days
Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Hypoglycemic(oral medication)
Lasso di tempo: 84days
Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Control blood pressure(oral medication)
Lasso di tempo: 84days
Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Lipid modifying (oral medication)
Lasso di tempo: 84days
Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chonbuk National University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2010

Completamento primario (Effettivo)

1 gennaio 2011

Completamento dello studio (Effettivo)

1 febbraio 2011

Date di iscrizione allo studio

Primo inviato

29 ottobre 2012

Primo inviato che soddisfa i criteri di controllo qualità

9 novembre 2012

Primo Inserito (Stima)

12 novembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 novembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2012

Ultimo verificato

1 novembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CUH_KOREAN-FOOD_2-2_2010

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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