Effect of the Healthy Cantonese Diet on Cardiometabolic Syndrome in Chinese Adults
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- Glucose metabolism
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: the healthy Cantonese diet (Other)
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.
干预措施: the typical Cantonese diet (Other)
结局指标
主要结局
Glucose metabolism
时间窗: before and after 4-week intervention
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.
Metabolic syndrome score
时间窗: before and after 4-week intervention
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
时间窗: before and after 4-week intervention
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
时间窗: before and after 4-week intervention
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.
次要结局
- Blood biochemical marker(before and after 4-week intervention)
- Urinary sodium and potassium(before and after 4-week intervention)
- Intestinal microbiota composition(before and after 4-week intervention)
- Gut microbial gene richness(before and after 4-week intervention)
- Inflammatory biomarkers(before and after 4-week intervention)
- Cardiopulmonary function(before and after 4-week intervention)
- Endothelial function(before and after 4-week intervention)
- Body composition(before and after 4-week intervention)
- Body mass index (BMI)(before and after 4-week intervention)
- Ratio of waist to hip circumference (WHR)(before and after 4-week intervention)
研究者
Huilian Zhu
Professor
Sun Yat-sen University