Clinical trial NCT04064281: The Healthy Cantonese Diet on Cardiometabolic Syndrome
Official title: Effect of the Healthy Cantonese Diet on Cardiometabolic Syndrome in Chinese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
High Blood Pressure
Hypertension
Hyperlipidemias
Hyperglycemia
Keywords: DASH
diet
trial
cardiovascular disease
blood pressure
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic syndrome score
timeFrame: before and after 4-week intervention
measure: Systolic blood pressure and diastolic blood pressure
timeFrame: before and after 4-week intervention
measure: Blood lipid profile
timeFrame: before and after 4-week intervention
measure: Glucose metabolism
timeFrame: before and after 4-week intervention
Secondary outcomes:
measure: Blood biochemical marker
timeFrame: before and after 4-week intervention
measure: Urinary sodium and potassium
timeFrame: before and after 4-week intervention
measure: Intestinal microbiota composition
timeFrame: before and after 4-week intervention
measure: Gut microbial gene richness
timeFrame: before and after 4-week intervention
measure: Inflammatory biomarkers
timeFrame: before and after 4-week intervention
measure: Cardiopulmonary function
timeFrame: before and after 4-week intervention
measure: Endothelial function
timeFrame: before and after 4-week intervention
measure: Body composition
timeFrame: before and after 4-week intervention
measure: Body mass index (BMI)
timeFrame: before and after 4-week intervention
measure: Ratio of waist to hip circumference (WHR)
timeFrame: before and after 4-week intervention
Other outcomes:
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