Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes
9 de novembro de 2012 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
48
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Jeollabuk-do
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Jeonju, Jeollabuk-do, Republica da Coréia, 560-822
- Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
19 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
Outros nomes:
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Comparador Ativo: Control group
Control group : told to "eat as usal diet) for 12weeks
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Told to " eat as usal diets".
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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HbA1C :Glycated Hemoglobin
Prazo: 84days
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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TG :Triglycerides
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 84days
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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
Prazo: 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
Prazo: 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
Prazo: 84days
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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
|
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ApoB :Apolipoprotein B
Prazo: 84days
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Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
|
84days
|
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Apo E :Apolipoprotein E
Prazo: 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
Prazo: 84days
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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
Prazo: 84days
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 84days
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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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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weight
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 84days
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Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
|
84days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2010
Conclusão Primária (Real)
1 de janeiro de 2011
Conclusão do estudo (Real)
1 de fevereiro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
29 de outubro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de novembro de 2012
Primeira postagem (Estimativa)
12 de novembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de novembro de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de novembro de 2012
Última verificação
1 de novembro de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CUH_KOREAN-FOOD_2-2_2010
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