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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07378033
Eligibility Criteria:
Inclusion Criteria:
1. Adult males and non-pregnant females aged 19 to 65 years
2. Individuals with a BMI of 25-32kg/m2 who are not taking any obesity related medicines.
3. Able to comply with all required study procedures and schedule.
4. Able to comply and willing to follow the prescribed diet plan.
5. Willing and able to give written informed consent.
Exclusion Criteria:
1. Individuals who experienced a weight change of 5% or more within 3 months prior to the screening.
2. Individuals who have taken or used medications, herbal remedies, or health supplements (including probiotics) for anti- obesity purposes (e.g., energy metabolism, appetite suppression, weight control, fat breakdown, carbohydrate blocking, inhibition of fat absorption, or gastrointestinal activity regulation) within 6 months prior to the screening.
3. Individuals who have participated in or experienced a weight-loss program within 3 months prior to the screening.
4. Individuals with Gastrointestinal disease like Crohn's Disease, Inflammatory Bowel Syndrome, Gastric resection, Chronic Inflammation (Kidney, Liver, Pancreas), infectious diseases, Autoimmune diseases, Malabsorption syndrome, Porphyria, Hepatitis B or C carriers.
5. Individuals currently using immunosuppressants; proton pump inhibitors (PPIs), H2 receptor blockers, or nonsteroidal anti-inflammatory drugs (NSAIDs); insulin; thyroid hormone replacement therapy.
6. Individuals who have taken Appetite suppressants, Semaglutide, OTC weight loss supplements 3 to 6 months before the trial.
7. Individuals who have consistently consumed dietary supplements (including protein supplements), teas, beverages, or jellies for weight control or fat reduction purposes.
8. Individuals who have undergone any obesity surgery or any surgery within the last 6 months.
9. Individuals who have consistently taken medications or health supplements for cholesterol improvement or blood circulation enhancement within 6 months prior to the screening.
10. Individuals who have clinically significant diseases or disorders related to the liver, kidneys, pancreas, biliary system, cardiovascular system, respiratory system, endocrine system (e.g., diabetes, thyroid disorders), or central nervous system, or who have malignant tumors as identified in physical or clinical examinations (except those who have not experienced recurrence for over 5 years post-surgery).
11. Individuals with uncontrolled hypertension (systolic blood pressure greater or equal to 160 mmHg or diastolic blood pressure greater or equal to 100 mmHg).
12. Individuals diagnosed with diabetes and taking medications to control blood sugar.
13. Individuals undergoing psychiatric medication or psychotherapy for eating disorders or other mental disorders.
14. Individuals with a history of clinically significant hypersensitivity reactions or those who may exhibit hypersensitivity to the ingredients or similar components of the investigational product.
15. Individuals who have consistently used functional products for cellulite removal or fat breakdown.
16. Heavy smokers (greater or equal to 20 cigarettes/day).
17. Individuals who excessively consume alcohol (greater or equal to 40 g/day for men or greater or equal to20 g/day for women).
18. Individuals whose diagnostic or medical test results at the screening visit show the following AST, ALT, or gamma GTP levels exceeding three times the upper limit of the laboratory reference range. eGFR less 60 mL/min/1.73 m square.
19. Individuals who have participated in other clinical trials or human application studies within 3 months prior to the screening.
20. Pregnant or lactating women or within 6 months of giving birth
21. Individuals deemed unsuitable for participation in the study by the principal investigator based on diagnostic laboratory results or other reasons
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT07378033
Study Brief:
Protocol Section:
NCT07378033