DietNCT03856762
Dietary Pattern and Metabolic Health Study
A study testing traditional Jiangnan diet, Mediterranean diet and Current Shanghai diet in people with Diet and PreDiabetes, run by Chinese Academy of Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Diet, PreDiabetes, Weight Loss
- What is being tested?
- traditional Jiangnan diet, Mediterranean diet and Current Shanghai diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 25 to 60 years old
- 24.0 ≤ BMI ≤ 40.0 kg/m2
- fasting glucose≥5.6 mmol/L
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital; SAIC FAW-Volkswagen Automobile Co
Shanghai, Shanghai Municipality, 200031
About this 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.
Read the 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.
- Conditions
- Diet, PreDiabetes, Weight Loss
- Being tested
- traditional Jiangnan diet, Mediterranean diet, Current Shanghai diet
- Medical subject headings
- Prediabetic State, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Jiangnan dietDietary supplement
traditional Jiangnan diet supplement from Monday to Friday for six months
Mediterranean dietDietary supplement
Mediterranean diet supplement from Monday to Friday for six months
Current Shanghai dietDietary supplement
current Shanghai diet supplement from Monday to Friday for six months
| Study group | Role | What they receive |
|---|---|---|
| Traditional Jiangnan diet | Experimental | Subjects will be supplied with traditional Jiangnan diet and APP-based behavioral modification Receives: Dietary Supplement: traditional Jiangnan diet |
| Mediterranean diet | Experimental | Subjects will be supplied with Mediterranean diet and APP-based behavioral modification Receives: Dietary Supplement: Mediterranean diet |
| Current Shanghai diet | Experimental | Subjects will be supplied with current Shanghai diet and APP-based behavioral modification Receives: Dietary Supplement: Current Shanghai diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be assessed by electronic scale (Seca-882; ScalesGalore) during each visit and Wi-Fi scale at home
Measured: 6 months
Glucose homeostasis
Glucose homeostasis will be assessed by Continuous Glucose Monitoring(FreeStyle Libre)
Measured: 6 months
Glucose
Glucose will be assessed by oral glucose tolerance test
Measured: 6 months
Secondary outcomes (7)
Abdominal fat
Abdominal fat will be assessed using Magnetic Resonance Imaging
Measured: 6 months
Blood pressure
Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron HEM-7000)
Measured: 6 months
Total cholesterol
Total cholesterol will be assessed using an automatic biochemical analyzer
Measured: 6 months
Triglyceride
Triglyceride will be assessed using an automatic biochemical analyzer
Measured: 6 months
LDL-C
LDL-C will be assessed using an automatic biochemical analyzer
Measured: 6 months
HDL-C
HDL-C will be assessed using an automatic biochemical analyzer
Measured: 6 months
HbA1c
HbA1c will be assessed using liquid Chromatograph Mass Spectrometer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Ruijin Hospital
- Responsible party
- Principal investigator, Xu Lin, Chinese Academy of Sciences
- Investigators
- Xu Lin, PhD, Principal investigator, Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856762
- Sponsor's protocol ID
- CAS-HDP-201902
- Status last verified
- Aug 2020
- First submitted
- 21 Feb 2019
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40270326Lin 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.
PubMed 39418916Luo 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.
PubMed 35579171
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Pattern and Metabolic Health Study
- ClinicalTrials.gov ID
- NCT03856762
- Acronym / sponsor ID
- CAS-HDP-201902
- Conditions
- Diet, PreDiabetes, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Ruijin Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Jiangnan diet | Experimental | Dietary Supplement: traditional Jiangnan dietSubjects will be supplied with traditional Jiangnan diet and APP-based behavioral modification |
| Mediterranean diet | Experimental | Dietary Supplement: Mediterranean dietSubjects will be supplied with Mediterranean diet and APP-based behavioral modification |
| Current Shanghai diet | Experimental | Dietary Supplement: Current Shanghai dietSubjects will be supplied with current Shanghai diet and APP-based behavioral modification |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 25 to 60 years old
- 24.0 ≤ BMI ≤ 40.0 kg/m2
- fasting glucose≥5.6 mmol/L
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional Jiangnan diettraditional Jiangnan diet supplement from Monday to Friday for six months | Dietary supplement | Traditional Jiangnan diet |
| Mediterranean dietMediterranean diet supplement from Monday to Friday for six months | Dietary supplement | Mediterranean diet |
| Current Shanghai dietcurrent Shanghai diet supplement from Monday to Friday for six months | Dietary supplement | Current Shanghai diet |
Primary outcome
Body weight
Time frame: 6 months
Body weight will be assessed by electronic scale (Seca-882; ScalesGalore) during each visit and Wi-Fi scale at home
Glucose homeostasis
Time frame: 6 months
Glucose homeostasis will be assessed by Continuous Glucose Monitoring(FreeStyle Libre)
Glucose
Time frame: 6 months
Glucose will be assessed by oral glucose tolerance test
7 secondary outcomes
Abdominal fat
Time frame: 6 months
Blood pressure
Time frame: 6 months
Total cholesterol
Time frame: 6 months
Triglyceride
Time frame: 6 months
LDL-C
Time frame: 6 months
HDL-C
Time frame: 6 months
HbA1c
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Derived from this study: PubMed 40270326Ni 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.
- Derived from this study: PubMed 39418916Lin 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.
- Derived from this study: PubMed 35579171Luo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Lin, PhD principal investigator
Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional Jiangnan diet, Mediterranean diet and Current Shanghai diet in people with Diet and PreDiabetes, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856762, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.