Dietary Pattern and Metabolic Health Study
Primary Purpose
Diet, PreDiabetes, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional Jiangnan diet
Mediterranean diet
Current Shanghai diet
Sponsored by
About this trial
This is an interventional prevention trial for Diet
Eligibility Criteria
Inclusion Criteria:
- Age between 25 to 60 years old
- 24.0 ≤ BMI ≤ 40.0 kg/m2
- fasting glucose≥5.6 mmol/L
Exclusion Criteria:
- Diabetes or use of insulin or other hypoglycemic medications
- Pregnancy or lactation
- Trying to change body weight in the way
- Use of antibiotic in the preceding 3 months for 3-serial days
- Obvious changes of medication in the preceding 3 months
- History of drug or alcohol abuse or other substance abuse; (Alcohol abuse is defined as regular alcohol consumption > 40 g/day)
- Any severe liver or renal diseases
- Severe gastrointestinal diseases
- Surgical events preceding 1 year (except appendicitis or hernia surgery)
- Severe cardiovascular or cerebrovascular diseases or phase three hypertension
- Implantation of heart stent
- Cancer or receiving radiotherapy and chemotherapy within 5 years
- Hyperthyroidism or hypothyroidism
- Suffering from hepatitis B, tuberculosis, AIDS and other infectious diseases
- Any mental disorders or current use of antidepressants
- Food contraindications or allergies to foods included in the intervention
- Cognitive disability
- Participated in any other clinical studies within 3 months
Sites / Locations
- Ruijin hospital; SAIC FAW-Volkswagen Automobile Co
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Traditional Jiangnan diet
Mediterranean diet
Current Shanghai diet
Arm Description
Subjects will be supplied with traditional Jiangnan diet and APP-based behavioral modification
Subjects will be supplied with Mediterranean diet and APP-based behavioral modification
Subjects will be supplied with current Shanghai diet and APP-based behavioral modification
Outcomes
Primary Outcome Measures
Body weight
Body weight will be assessed by electronic scale (Seca-882; ScalesGalore) during each visit and Wi-Fi scale at home
Glucose homeostasis
Glucose homeostasis will be assessed by Continuous Glucose Monitoring(FreeStyle Libre)
Glucose
Glucose will be assessed by oral glucose tolerance test
Secondary Outcome Measures
Abdominal fat
Abdominal fat will be assessed using Magnetic Resonance Imaging
Blood pressure
Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron HEM-7000)
Total cholesterol
Total cholesterol will be assessed using an automatic biochemical analyzer
Triglyceride
Triglyceride will be assessed using an automatic biochemical analyzer
LDL-C
LDL-C will be assessed using an automatic biochemical analyzer
HDL-C
HDL-C will be assessed using an automatic biochemical analyzer
HbA1c
HbA1c will be assessed using liquid Chromatograph Mass Spectrometer
Full Information
NCT ID
NCT03856762
First Posted
February 21, 2019
Last Updated
August 22, 2020
Sponsor
Chinese Academy of Sciences
Collaborators
Ruijin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03856762
Brief Title
Dietary Pattern and Metabolic Health Study
Official Title
Dietary Pattern and Metabolic Health Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, PreDiabetes, Weight Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Jiangnan diet
Arm Type
Experimental
Arm Description
Subjects will be supplied with traditional Jiangnan diet and APP-based behavioral modification
Arm Title
Mediterranean diet
Arm Type
Experimental
Arm Description
Subjects will be supplied with Mediterranean diet and APP-based behavioral modification
Arm Title
Current Shanghai diet
Arm Type
Experimental
Arm Description
Subjects will be supplied with current Shanghai diet and APP-based behavioral modification
Intervention Type
Dietary Supplement
Intervention Name(s)
traditional Jiangnan diet
Intervention Description
traditional Jiangnan diet supplement from Monday to Friday for six months
Intervention Type
Dietary Supplement
Intervention Name(s)
Mediterranean diet
Intervention Description
Mediterranean diet supplement from Monday to Friday for six months
Intervention Type
Dietary Supplement
Intervention Name(s)
Current Shanghai diet
Intervention Description
current Shanghai diet supplement from Monday to Friday for six months
Primary Outcome Measure Information:
Title
Body weight
Description
Body weight will be assessed by electronic scale (Seca-882; ScalesGalore) during each visit and Wi-Fi scale at home
Time Frame
6 months
Title
Glucose homeostasis
Description
Glucose homeostasis will be assessed by Continuous Glucose Monitoring(FreeStyle Libre)
Time Frame
6 months
Title
Glucose
Description
Glucose will be assessed by oral glucose tolerance test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Abdominal fat
Description
Abdominal fat will be assessed using Magnetic Resonance Imaging
Time Frame
6 months
Title
Blood pressure
Description
Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron HEM-7000)
Time Frame
6 months
Title
Total cholesterol
Description
Total cholesterol will be assessed using an automatic biochemical analyzer
Time Frame
6 months
Title
Triglyceride
Description
Triglyceride will be assessed using an automatic biochemical analyzer
Time Frame
6 months
Title
LDL-C
Description
LDL-C will be assessed using an automatic biochemical analyzer
Time Frame
6 months
Title
HDL-C
Description
HDL-C will be assessed using an automatic biochemical analyzer
Time Frame
6 months
Title
HbA1c
Description
HbA1c will be assessed using liquid Chromatograph Mass Spectrometer
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 25 to 60 years old
24.0 ≤ BMI ≤ 40.0 kg/m2
fasting glucose≥5.6 mmol/L
Exclusion Criteria:
Diabetes or use of insulin or other hypoglycemic medications
Pregnancy or lactation
Trying to change body weight in the way
Use of antibiotic in the preceding 3 months for 3-serial days
Obvious changes of medication in the preceding 3 months
History of drug or alcohol abuse or other substance abuse; (Alcohol abuse is defined as regular alcohol consumption > 40 g/day)
Any severe liver or renal diseases
Severe gastrointestinal diseases
Surgical events preceding 1 year (except appendicitis or hernia surgery)
Severe cardiovascular or cerebrovascular diseases or phase three hypertension
Implantation of heart stent
Cancer or receiving radiotherapy and chemotherapy within 5 years
Hyperthyroidism or hypothyroidism
Suffering from hepatitis B, tuberculosis, AIDS and other infectious diseases
Any mental disorders or current use of antidepressants
Food contraindications or allergies to foods included in the intervention
Cognitive disability
Participated in any other clinical studies within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Lin, PhD
Organizational Affiliation
Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin hospital; SAIC FAW-Volkswagen Automobile Co
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35579171
Citation
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.
Results Reference
derived
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Dietary Pattern and Metabolic Health Study
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