Dietary Pattern and Metabolic Health Study
Condition: Diet; PreDiabetes; Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): traditional Jiangnan diet; Mediterranean diet; Current Shanghai diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention