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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Jiangnan diet | Experimental | Subjects will be supplied with traditional Jiangnan diet and APP-based behavioral modification |
|
| Mediterranean diet | Experimental | Subjects will be supplied with Mediterranean diet and APP-based behavioral modification |
|
| Current Shanghai diet | Experimental | Subjects will be supplied with current Shanghai diet and APP-based behavioral modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| traditional Jiangnan diet | Dietary Supplement | traditional Jiangnan diet supplement from Monday to Friday for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight will be assessed by electronic scale (Seca-882; ScalesGalore) during each visit and Wi-Fi scale at home | 6 months |
| Glucose homeostasis | Glucose homeostasis will be assessed by Continuous Glucose Monitoring(FreeStyle Libre) | 6 months |
| Glucose | Glucose will be assessed by oral glucose tolerance test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal fat | Abdominal fat will be assessed using Magnetic Resonance Imaging | 6 months |
| Blood pressure | Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron HEM-7000) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xu Lin, PhD | Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hospital; SAIC FAW-Volkswagen Automobile Co | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40270326 | Derived | Ni M, Chen Y, Gu W, Zhang Y, Xu M, Gu Y, Chen Y, Zhu Y, Wang X, Luo Y, Xu Y, Lin X, Zeng YA, Liu R, Wang J. Association Between Circulating Gremlin 2 and beta-Cell Function Among Participants With Prediabetes and Type 2 Diabetes. J Diabetes. 2025 Apr;17(4):e70090. doi: 10.1111/1753-0407.70090. | |
| 39418916 | Derived |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Mediterranean diet | Dietary Supplement | Mediterranean diet supplement from Monday to Friday for six months |
|
| Current Shanghai diet | Dietary Supplement | current Shanghai diet supplement from Monday to Friday for six months |
|
| 6 months |
| Total cholesterol | Total cholesterol will be assessed using an automatic biochemical analyzer | 6 months |
| Triglyceride | Triglyceride will be assessed using an automatic biochemical analyzer | 6 months |
| LDL-C | LDL-C will be assessed using an automatic biochemical analyzer | 6 months |
| HDL-C | HDL-C will be assessed using an automatic biochemical analyzer | 6 months |
| HbA1c | HbA1c will be assessed using liquid Chromatograph Mass Spectrometer | 6 months |
| Lin H, Wang Q, Gao A, Sun Y, Shen C, Chen Y, Wang Z, Xu X, Ni M, Chen Y, Zhang J, Luo Y, Lin X, Bi Y, Ning G, Wang W, Hong J, Gu W, Wang J, Liu R. Enteropancreatic hormone changes in caloric-restricted diet interventions associate with post-intervention weight maintenance. Clin Nutr. 2024 Dec;43(12):5-14. doi: 10.1016/j.clnu.2024.10.004. Epub 2024 Oct 5. |
| 35579171 | Derived | Luo Y, Wang J, Sun L, Gu W, Zong G, Song B, Shen C, Zhou P, Chen Y, Wu Y, Lin H, Zheng H, Ni M, Yang X, Chen Y, Xu X, Zhang J, Shi J, Zhang R, Hu J, Hou H, Lu L, Xu X, Liang L, Liu R, Liu X, Li H, Hong J, Wang W, Lin X, Ning G. Isocaloric-restricted Mediterranean Diet and Chinese Diets High or Low in Plants in Adults With Prediabetes. J Clin Endocrinol Metab. 2022 Jul 14;107(8):2216-2227. doi: 10.1210/clinem/dgac303. |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |