Weight Loss Clinical Trial
Official title:
Dietary Pattern and Metabolic Health Study
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.
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