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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

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:

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.

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

NCT ID

NCT04064281

First Posted

August 12, 2019

Last Updated

August 19, 2019

Sponsor

Sun Yat-sen University

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

Studies a U.S. FDA-regulated Device Product

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

Arm Title

the typical Cantonese diet

Arm Type

Placebo Comparator

Arm Description

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

Time Frame