This is a single-blind, randomized trial. Based on inclusion and exclusion criteria, 253 eligible volunteers, who were 25-60 years old, with overweight/obese and prediabetes are assigned to one of three dietary patterns: healthy Jiangnan, restricted-calorie; Mediterranean, restricted-calorie; or typical Shanghai, restricted-calorie. The Shanghai Institutes for Biological Sciences of the Chinese Academy of Sciences(CAS) cooperated with Ruijin Hospital to conduct the study which is funded by the CAS. The study' protocol has been approved by the Ethics Committee of Shanghai Institutes for Biological Sciences. The main purpose of this study is to clarify: the efficacy of traditional Jiangnan dietary pattern, Mediterranean dietary pattern and the current Shanghai dietary pattern in improving overweight/obesity, glucose homeostasis, other cardiovascular metabolic risk factors and their main regulatory factors in Chinese.
Nowadays, the prevalence of type 2 diabetes and its related metabolic diseases is rapidly rising in China. Obesity and early pathoglycemia will increase the risk of diabetes and related cardiovascular diseases severely. Therefore, more effective methods and strategies need to be found to reduce body weight, improve pathoglycemia, and control the development of this high-risk group to type 2 diabetes. As the most popular healthy dietary pattern in the world, the role of Mediterranean diet in the prevention of type 2 diabetes remains unclear. In addition, the protective role of Chinese traditional dietary pattern with lots of plant-based foods in the region of Jiangnan has not been clarified through intervention studies. Therefore, it is urgent to explore the feasibility and effectiveness of traditional Jiangnan diet and Mediterranean diet through dietary intervention studies in Chinese. The effectiveness of healthy dietary patterns can be further enhanced by limiting dietary intake to achieve weight loss. Recently, the Spainish study found that energy-restricted Mediterranean diet + physical activity + behavioral interventions are more conducive to weight loss in overweight/obesity with prediabetes/type 2 diabetes compared with conventional Mediterranean dietary interventions. The 2019 Diabetes Management Standard of American Diabetes Association re-emphasizes the importance of moderate weight loss for delaying the progression of type 2 diabetes, and recommends that a reduction in dietary intake is 500-750 kcal/day to reach 1-2 pounds per week is suitable. At the same time, the American Clinical Endocrine Society and the American Endocrine Society have also updated the 2019 Comprehensive Management Guide for Type 2 Diabetes. The new guidelines point out that all overweight or obese patients with prediabetes or type 2 diabetes should pay attention to weight loss. And weight loss treatment should include specific lifestyle interventions, including calorie-restricted healthy dietary plan, physical activity and behavioral interventions. Dietary intervention studies in the past mainly relied on dietary education. However, this study now provides a healthy and reasonable dietary model for the Chinese population through lifestyle intervention to clarify the improvement of cardiovascular metabolic risk such as overweight/obesity, glucose homeostasis, and the scientific basis for establishing a healthy dietary model which is suitable for Chinese population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
253
traditional Jiangnan diet supplement from Monday to Friday for six months
Mediterranean diet supplement from Monday to Friday for six months
current Shanghai diet supplement from Monday to Friday for six months
Ruijin hospital; SAIC FAW-Volkswagen Automobile Co
Shanghai, Shanghai Municipality, China
Body weight
Body weight will be assessed by electronic scale (Seca-882; ScalesGalore) during each visit and Wi-Fi scale at home
Time frame: 6 months
Glucose homeostasis
Glucose homeostasis will be assessed by Continuous Glucose Monitoring(FreeStyle Libre)
Time frame: 6 months
Glucose
Glucose will be assessed by oral glucose tolerance test
Time frame: 6 months
Abdominal fat
Abdominal fat will be assessed using Magnetic Resonance Imaging
Time frame: 6 months
Blood pressure
Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron HEM-7000)
Time frame: 6 months
Total cholesterol
Total cholesterol will be assessed using an automatic biochemical analyzer
Time frame: 6 months
Triglyceride
Triglyceride will be assessed using an automatic biochemical analyzer
Time frame: 6 months
LDL-C
LDL-C will be assessed using an automatic biochemical analyzer
Time frame: 6 months
HDL-C
HDL-C will be assessed using an automatic biochemical analyzer
Time frame: 6 months
HbA1c
HbA1c will be assessed using liquid Chromatograph Mass Spectrometer
Time frame: 6 months
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