Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT06401161
Eligibility Criteria:
Inclusion Criteria:
The A、B should be simultaneously met, or combined with the C、D、E.
1. 18-65 years, priority for patients over 30 years;
2. Overweight / obese patients: BMI ≥24 kg/m2.
3. Or combined with nonalcoholic fatty liver disease: determined by the hospital MRI nuclear magnetic quantification;
4. Or combined with dyslipidemia: blood total cholesterol TC≥6.4mmol/L or blood total triglyceride TG≥2.0mmol/L or blood low-density lipoprotein LDL-C≥3.1mmol/L;
5. Or with abnormal blood glucose:
* Impaired fasting glucose, IFG: fasting blood glucose was 6.1\~\<7.0mmol/L,and 2 hours after 75g oral blood glucose tolerance test(OGTT) \<7.8mmol / L.
* Impaired glucose tolerance, IGT: the fasting blood glucose was \<6.1mmol/L and 2 hours after 75gOGTT was 7.8\~ \<11.1 mmol / L;
* IFG with IGT: patients with both IFG and IGT;
* Patients with type 2 diabetes: random blood glucose 11.1mmol/L or fasting glucose of 7.0 mmol/L or 2 hours after OGTT.
Exclusion Criteria:
1. Type 2 diabetes and insulin injections or oral hypoglycemic drugs and other special types of diabetes.
2. For women during pregnancy or lactation or with allergies;
3. Patients treated with any hypoglycemic drugs and insulin injections; regular or planned patients taking drugs that may affect glucose and lipid metabolism (as judged by clinicians, such as diet pills, lipid-lowering drugs) and liver protection drugs (as judged by clinicians);
4. Patients with severe cardiovascular diseases, cerebrovascular diseases, liver, kidney, and hematopoietic diseases;
5. Combined with other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome;
6. Take probiotics, prebiotics, antioxidants and fish oil nutrient supplements within 3 months;
7. Current smokers and regular drinking (excluding social drinkers only);
8. Yogurt intake within 1 week before the first visit and antibiotics within 3 months;
9. Drink strong tea regularly;
10. Participate in other clinical trials within 3 months;
11. Unable not cooperate with the investigator for other reasons.
12. Unfit for the researcherr.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06401161
Study Brief:
Protocol Section:
NCT06401161