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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT06974266
Eligibility Criteria:
Inclusion Criteria:
1. Aged 40-60 years (inclusive), regardless of gender;
2. Patients diagnosed with hypercholesterolemia (5.2 mmol/L ≤ TC \<6.2 mmol/L, or 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L), with or without hypertriglyceridemia (1.7 mmol/L ≤ TG \<4.5 mmol/L) or mixed hyperlipidemia (defined as: 1.7 mmol/L ≤ TG \<4.5 mmol/L and 5.2 mmol/L ≤ TC \<6.2 mmol/L; or 1.7 mmol/L ≤ TG \<4.5 mmol/L and 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L; or 1.7 mmol/L ≤ TG \<4.5 mmol/L, 5.2 mmol/L ≤ TC \<6.2 mmol/L and 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L);
3. Accompanied by overweight/obesity (24.0 ≤ BMI ≤40.0 kg/m²);
4. Have not taken any metabolic control medications (for lipid, weight, or blood glucose) within the past month;
5. Have controlled of blood lipids solely through lifestyle interventions (diet and exercise) for at least 1 month prior to the screening period;
6. People must possess communication and cognitive abilities to adhere to long-term medication, and fully understand the nature, significance, potential benefits, inconveniences, and risks of the study before participation;
7. Fertile patients (male or female) must agree to use at least one medically approved contraceptive method (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during the trial. Female with childbearing potential must have a negative blood pregnancy test during screening and must not be lactating;
8. Voluntary enrollment with signed informed consent, and commitment to comply with the trial treatment regimen and visit schedule
Exclusion Criteria:
1. Have taken any metabolic control medications (e.g., lipid-lowering, blood glucose-regulating, or weight-loss drugs) within the past month or are currently taking such medications.
2. Patients with secondary hyperlipidemia caused by conditions such as nephrotic syndrome, liver diseases, hypothyroidism, renal failure, etc..
3. Have severe comorbidities requiring immediate treatment, including uncontrolled diabetes, hypertriglyceridemia, cerebrovascular diseases, etc., as determined by the investigator.
4. Have severe primary diseases (e.g., hepatic, renal, or hematopoietic system disorders) or psychiatric conditions.
5. Patients with a family history of genetically inherited metabolic disorders.
6. Currently taking liver-affecting medications.
7. Have a history of bariatric surgery.
8. People with acute or chronic progressive/unstable diseases deemed unsuitable for enrollment by the investigator.
9. Hepatic or renal dysfunction: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5×upper limit of normal (ULN); Total bilirubin \>1.5×ULN; Serum creatinine (Cr) \>1.5×ULN.
10. Serum amylase ≥1.5×ULN or other clinically significant laboratory abnormalities per investigator judgment.
11. Patients with acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) within the past 3 months.
12. Have a history of gastrointestinal surgery within the past year.
13. People with allergic constitution or hypersensitivity to the investigational product.
14. Have used antibiotics, probiotics, or prebiotics within 3 months prior to recruitment.
15. Excessive alcohol consumption in the past decade (\>30 g/day for males; \>20 g/day for females).
16. Pregnant or breastfeeding subjects.
17. Excluded for other reasons as determined by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT06974266
Study Brief:
Protocol Section:
NCT06974266