The Healthy Cantonese Diet on Cardiometabolic Syndrome
19 de agosto de 2019 atualizado por: Huilian Zhu, Sun Yat-sen University
Effect of the Healthy Cantonese Diet on Cardiometabolic Syndrome in Chinese Adults
The DASH diet (Dietary Approaches to Stop Hypertension) have been proven to lower risk of cardiovascular diseases.
But the DASH diet is inconsistent with Chinese dietary pattern.
In this study, based on the typical Cantonese diet, the healthy Cantonese diet is developed according to the DASH diet and the balanced dietary pattern of the Chinese Dietary Guidelines 2016.
The randomized control trial is designed to investigate whether the healthy Cantonese diet has benefit to blood pressure, blood lipid, blood glucose and other cardiometabolic biomarkers among adults with cardiometabolic syndrome in Guangdong, China.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
90
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.
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
25 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age 25-75 years old, male or female;
- have lived in this community for the past six months, and have no plans to move out or go out in the next three months;
- the systolic blood pressure is within 130-159mmHg regardless of medication.
- maintaining the current medication (mainly drugs for hypertension, diabetes or hyperlipidemia) throughout the research period, with the category and dose unchanged;
- the number of test meal consumed is no less than 18;
- community feeding mode: eat a meal at least once a day at the research center (preferably lunch or dinner); or home delivery mode: upload meal pictures for three meals every day, and eat a meal and have physical examination at the research center at least once a week;
- sign the informed consent form.
Exclusion Criteria:
- fasting blood glucose ≥10.0mmol/L;
- total cholesterol ≥7.2mmol/L;
- injected inulin within a month;
- unwilling or unable to change the original dietary pattern, or have special dietary needs (such as vegetarians);
- alcoholism;
- BMI ≥30kg/m^2, or losing weight currently;
- have acute cardiovascular and cerebrovascular events occurred in the past six months;
- have a history of chronic kidney disease, intestinal irritation or asthma;
- women who have been/are preparing for pregnancy or lactation;
- in combination with other serious diseases such as cancer, chronic heart failure, severe depression or other mental disorders, long-term bedridden or unable to move freely;
- have a history of common food allergies (eggs, seafood, peanuts, etc.);
- have undergone gastrointestinal surgery;
- currently suffering from acute phase of diseases such as respiratory infections, fever, severe diarrhea;
- have deaf-mutism, dementia, unable to communicate properly.
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: the healthy Cantonese diet
Based on the typical Cantonese diet, the healthy Cantonese diet is developed according to the DASH diet and the balanced dietary pattern of the Chinese Dietary Guidelines 2016.
In this diet, the main nutrients, dietary fiber, sodium, calcium, magnesium and potassium are set to achieve the healthy goal.
Compared with the typical Cantonese diet, the healthy Cantonese diet is increased in fruit, vegetables, low-fat dairy products, whole grains, nuts and seeds, and reduced in salt, oil and sweets.
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After a 1-week run-in period, the intervention group will eat the healthy Cantonese diet for 4 consecutive weeks.
Free meals will be provided 3 times a day (breakfast, lunch, dinner).
The actually intake of every meal for all subjects will be recorded to estimate their nutrients intake.
All subjects will be advised to avoid eating other food, but they should inform researchers of what they eat if they eat food that we will not provide.
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Comparador de Placebo: the typical Cantonese diet
The typical Cantonese diet is a diet of what many Cantonese eat.
In this diet, the main nutrients, dietary fiber, sodium, calcium, magnesium and potassium are set at the average dietary intake levels in Guangdong.
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After a 1-week run-in period, the control group will still eat the typical Cantonese diet for 4 consecutive weeks.
Free meals will be provided 3 times a day (breakfast, lunch, dinner).
The actually intake of every meal for all subjects will be recorded to estimate their nutrients intake.
All subjects will be advised to avoid eating other food, but they should inform researchers of what they eat if they eat food that we will not provide.
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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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Metabolic syndrome score
Prazo: before and after 4-week intervention
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Changes of metabolic syndrome score in healthy Cantonese diet compared with changes of typical Cantonese diet.
Metabolic syndrome score will be derived by standardizing and then summing the following continuously distributed indices of adiposity (waist circumference) to create a z score: hypertension (the average of systolic blood pressure and diastolic blood pressure); hyperglycaemia (fasting plasma glucose); insulin resistance (fasting insulin); fasting HDL-cholesterol × -1; and fasting triacylglycerol z score.
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before and after 4-week intervention
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Systolic blood pressure and diastolic blood pressure
Prazo: before and after 4-week intervention
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Changes of systolic blood pressure and diastolic blood pressure in healthy Cantonese diet compared with changes of typical Cantonese diet.
Blood pressure will be measured by trained investigator at baseline, week 1, week 2, week 3 and week 4, and systolic blood pressure and diastolic blood pressure will be recorded.
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before and after 4-week intervention
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Blood lipid profile
Prazo: before and after 4-week intervention
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Changes of blood lipid profile in healthy Cantonese diet compared with changes of typical Cantonese diet.
Blood lipid profile (total cholesterol, TC; triglyceride, TG; LDL cholesterol, LDLc; HDL cholesterol, HDLc) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4.
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before and after 4-week intervention
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Glucose metabolism
Prazo: before and after 4-week intervention
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Changes of glucose metabolism in healthy Cantonese diet compared with changes of typical Cantonese diet.
Glucose metabolism (fasting plasma glucose and fasting insulin) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4 and insulin resistance index (HOMA-IR) will be calculated by [fasting insulin (mU/L) × fasting plasma glucose (mmol/L) ]/22.5.
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before and after 4-week intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood biochemical marker
Prazo: before and after 4-week intervention
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Changes of blood biochemical marker in healthy Cantonese diet compared with changes of typical Cantonese diet.
Blood biochemical marker (calcium, potassium, sodium, magnesium and phosphorus in mmol/L; uric acid in μmol/L) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4.
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before and after 4-week intervention
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Urinary sodium and potassium
Prazo: before and after 4-week intervention
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Changes of urinary sodium and potassium in healthy Cantonese diet compared with changes of typical Cantonese diet.
Urinary sodium and potassium will be tested by a validated biomedical analyses laboratory using morning urine at baseline and week 4.
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before and after 4-week intervention
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Intestinal microbiota composition
Prazo: before and after 4-week intervention
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Changes of intestinal microbiota composition in healthy Cantonese diet compared with changes of typical Cantonese diet.
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before and after 4-week intervention
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Gut microbial gene richness
Prazo: before and after 4-week intervention
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Changes of gut microbial gene richness in healthy Cantonese diet compared with changes of typical Cantonese diet.
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before and after 4-week intervention
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Inflammatory biomarkers
Prazo: before and after 4-week intervention
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Changes of inflammatory biomarkers in healthy Cantonese diet compared with changes of typical Cantonese diet.
Inflammatory biomarkers (CRP in mg/L; Tumor TNF-α and IL-6 in ng/L) will be tested by a validated biomedical analyses laboratory using vein serum at baseline and week 4.
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before and after 4-week intervention
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Cardiopulmonary function
Prazo: before and after 4-week intervention
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Changes of cardiopulmonary function in healthy Cantonese diet compared with changes of typical Cantonese diet.
Cardiopulmonary function will be measured by cardiopulmonary exercise testing using CORTEX MetaLyzer 3B at baseline and week 4.
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before and after 4-week intervention
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Endothelial function
Prazo: before and after 4-week intervention
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Changes of endothelial function in healthy Cantonese diet compared with changes of typical Cantonese diet.
Flow-mediated dilatation (FMD) will be assessed to evaluate endothelial function by using UNEX EF38G at baseline and week 4.
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before and after 4-week intervention
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Body composition
Prazo: before and after 4-week intervention
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Changes of body composition in healthy Cantonese diet compared with changes of typical Cantonese diet.
Body composition will be tested by using dual energy X-ray absorptiometry at baseline and week 4.
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before and after 4-week intervention
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Body mass index (BMI)
Prazo: before and after 4-week intervention
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Height in meters and weight in kilograms will be combined to report body mass index (BMI) in kg/m^2.
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before and after 4-week intervention
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Ratio of waist to hip circumference (WHR)
Prazo: before and after 4-week intervention
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Waist circumference in centimeters and hip circumference in centimeters will be combined to report ratio of waist to hip circumference (WHR).
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before and after 4-week intervention
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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 (Antecipado)
1 de setembro de 2019
Conclusão Primária (Antecipado)
31 de dezembro de 2021
Conclusão do estudo (Antecipado)
31 de dezembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
12 de agosto de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de agosto de 2019
Primeira postagem (Real)
21 de agosto de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de agosto de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de agosto de 2019
Última verificação
1 de agosto de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CC-2019-03
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Estuda um medicamento regulamentado pela FDA dos EUA
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