The Healthy Cantonese Diet on Cardiometabolic Syndrome
19 de agosto de 2019 actualizado 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.
Descripción general del estudio
Estado
Estado
Desconocido
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
Inscripción
90
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Huilian Zhu, professor
- Número de teléfono: +86 20 87331811
- Correo electrónico: zhuhl@mail.sysu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Aiping Fang
- Número de teléfono: +86 20 87335875
- Correo electrónico: fangaip@mail.sysu.edu.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
25 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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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 placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Metabolic syndrome score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood biochemical marker
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Inicio del estudio
1 de septiembre de 2019
Finalización primaria (Anticipado)
Finalización primaria
31 de diciembre de 2021
Finalización del estudio (Anticipado)
Finalización del estudio
31 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
12 de agosto de 2019
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
19 de agosto de 2019
Publicado por primera vez (Actual)
Publicado por primera vez
21 de agosto de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
21 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
19 de agosto de 2019
Última verificación
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- CC-2019-03
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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