The Healthy Cantonese Diet on Cardiometabolic Syndrome

NCT ID: NCT04064281

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-12-31

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; High Blood Pressure; Hypertension; Hyperlipidemias; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

the healthy Cantonese diet

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

the typical Cantonese diet

Intervention Type: OTHER

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.

Interventions

the healthy Cantonese diet

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

the typical Cantonese diet

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Huilian Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Huilian Zhu, professor

Role: CONTACT

zhuhl@mail.sysu.edu.cn

+86 20 87331811

Aiping Fang

Role: CONTACT

fangaip@mail.sysu.edu.cn

+86 20 87335875

Other Identifiers

CC-2019-03

Identifier Type: -

Identifier Source: org_study_id