The Healthy Cantonese Diet on Cardiometabolic Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia; Cardiovascular Diseases; Hypertension; Hyperlipidemias; Cardiovascular Risk Factor; High Blood Pressure
• Intervention / Treatment: Other: the healthy Cantonese diet; Other: the typical Cantonese diet

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and after 4-week intervention
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.	before and after 4-week intervention
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.	before and after 4-week intervention
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.	before and after 4-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and after 4-week intervention
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.	before and after 4-week intervention
Intestinal microbiota composition	Changes of intestinal microbiota composition in healthy Cantonese diet compared with changes of typical Cantonese diet.	before and after 4-week intervention
Gut microbial gene richness	Changes of gut microbial gene richness in healthy Cantonese diet compared with changes of typical Cantonese diet.	before and after 4-week intervention
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.	before and after 4-week intervention
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.	before and after 4-week intervention
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.	before and after 4-week intervention
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.	before and after 4-week intervention
Body mass index (BMI)	Height in meters and weight in kilograms will be combined to report body mass index (BMI) in kg/m^2.	before and after 4-week intervention
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).	before and after 4-week intervention

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: cardiovascular disease; blood pressure; trial; diet; DASH
• Additional Relevant MeSH Terms: Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Dyslipidemias; Hyperglycemia; Hypertension; Cardiovascular Diseases; Metabolic Syndrome; Hyperlipidemias
• Other Study ID Numbers: CC-2019-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No