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The Healthy Cantonese Diet on Cardiometabolic Syndrome

Primary Purpose

Cardiovascular Diseases, Cardiovascular Risk Factor, High Blood Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the healthy Cantonese diet
the typical Cantonese diet
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring DASH, diet, trial, cardiovascular disease, blood pressure

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 25-75 years old, male or female;
  2. 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;
  3. the systolic blood pressure is within 130-159mmHg regardless of medication.
  4. maintaining the current medication (mainly drugs for hypertension, diabetes or hyperlipidemia) throughout the research period, with the category and dose unchanged;
  5. the number of test meal consumed is no less than 18;
  6. 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;
  7. sign the informed consent form.

Exclusion Criteria:

  1. fasting blood glucose ≥10.0mmol/L;
  2. total cholesterol ≥7.2mmol/L;
  3. injected inulin within a month;
  4. unwilling or unable to change the original dietary pattern, or have special dietary needs (such as vegetarians);
  5. alcoholism;
  6. BMI ≥30kg/m^2, or losing weight currently;
  7. have acute cardiovascular and cerebrovascular events occurred in the past six months;
  8. have a history of chronic kidney disease, intestinal irritation or asthma;
  9. women who have been/are preparing for pregnancy or lactation;
  10. 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;
  11. have a history of common food allergies (eggs, seafood, peanuts, etc.);
  12. have undergone gastrointestinal surgery;
  13. currently suffering from acute phase of diseases such as respiratory infections, fever, severe diarrhea;
  14. have deaf-mutism, dementia, unable to communicate properly.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    the healthy Cantonese diet

    the typical Cantonese diet

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Metabolic syndrome score
    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.
    Systolic blood pressure and diastolic blood pressure
    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.
    Blood lipid profile
    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.
    Glucose metabolism
    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.

    Secondary Outcome Measures

    Blood biochemical marker
    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.
    Urinary sodium and potassium
    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.
    Intestinal microbiota composition
    Changes of intestinal microbiota composition in healthy Cantonese diet compared with changes of typical Cantonese diet.
    Gut microbial gene richness
    Changes of gut microbial gene richness in healthy Cantonese diet compared with changes of typical Cantonese diet.
    Inflammatory biomarkers
    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.
    Cardiopulmonary function
    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.
    Endothelial function
    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.
    Body composition
    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.
    Body mass index (BMI)
    Height in meters and weight in kilograms will be combined to report body mass index (BMI) in kg/m^2.
    Ratio of waist to hip circumference (WHR)
    Waist circumference in centimeters and hip circumference in centimeters will be combined to report ratio of waist to hip circumference (WHR).

    Full Information

    First Posted
    August 12, 2019
    Last Updated
    August 19, 2019
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04064281
    Brief Title
    The Healthy Cantonese Diet on Cardiometabolic Syndrome
    Official Title
    Effect of the Healthy Cantonese Diet on Cardiometabolic Syndrome in Chinese Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Cardiovascular Risk Factor, High Blood Pressure, Hypertension, Hyperlipidemias, Hyperglycemia
    Keywords
    DASH, diet, trial, cardiovascular disease, blood pressure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    All subjects will enter 1-week run-in feeding period during which they will eat the control diet. After a 1-week run-in period, subjects will be randomly divided into the intervention group and the control group, stratified by gender. The two groups will eat their assigned diet for 4 consecutive weeks.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Due to the particularity of dietary intervention studies, it is hard to blind researchers and kitchen staff. Therefore, this trial only blinds subjects. In order to ensure blinding, they will be not told which group they have been assigned and the two groups will eat their assigned diet in different rooms. And outcomes assessors will also be blinded to the two diet groups.
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    the healthy Cantonese diet
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    the typical Cantonese diet
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    the healthy Cantonese diet
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    the typical Cantonese diet
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Metabolic syndrome score
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Systolic blood pressure and diastolic blood pressure
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Blood lipid profile
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Glucose metabolism
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Secondary Outcome Measure Information:
    Title
    Blood biochemical marker
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Urinary sodium and potassium
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Intestinal microbiota composition
    Description
    Changes of intestinal microbiota composition in healthy Cantonese diet compared with changes of typical Cantonese diet.
    Time Frame
    before and after 4-week intervention
    Title
    Gut microbial gene richness
    Description
    Changes of gut microbial gene richness in healthy Cantonese diet compared with changes of typical Cantonese diet.
    Time Frame
    before and after 4-week intervention
    Title
    Inflammatory biomarkers
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Cardiopulmonary function
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Endothelial function
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Body composition
    Description
    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.
    Time Frame
    before and after 4-week intervention
    Title
    Body mass index (BMI)
    Description
    Height in meters and weight in kilograms will be combined to report body mass index (BMI) in kg/m^2.
    Time Frame
    before and after 4-week intervention
    Title
    Ratio of waist to hip circumference (WHR)
    Description
    Waist circumference in centimeters and hip circumference in centimeters will be combined to report ratio of waist to hip circumference (WHR).
    Time Frame
    before and after 4-week intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Huilian Zhu, professor
    Phone
    +86 20 87331811
    Email
    zhuhl@mail.sysu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aiping Fang
    Phone
    +86 20 87335875
    Email
    fangaip@mail.sysu.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

    The Healthy Cantonese Diet on Cardiometabolic Syndrome

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