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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT07009756
Eligibility Criteria:
Inclusion Criteria:
* Healthy, aged in the 20 - 60 range
* BMI (Body Mass Index) in the range of 18.5 - 29.9 kg/m2
* No underlying diseases
* No gastrointestinal surgery
* The fasting blood parameters of total cholesterol and LDL-C are higher than 200 mg/dL and 130 - 189 mg/dL, respectively.
* The fasting blood triglyceride must be less than 500 mg/dL.
* The fasting blood glucose must be less than 110 mg/dL.
* ALT (Alanine aminotransferase) and AST (Aspartate aminotransferase) must be less than 60 units/L.
* eGFR (estimated glomerular filtration rate) must be at least 90 mL/min/1.73 m2.
* Blood pressure must be less than 160/90 mmHg.
* Heart rate must be less than 100 times/minute.
* No smoking
* Be able to consume pork congee
Exclusion Criteria:
* Allergic to insects, chitin, chitosan, shrimp, dust mites, and other crustacean products
* Pregnant or breastfeeding
* Participating in other research projects, and receiving drugs, herbs, and supplements
* Receiving steroid, antibiotic, or other drugs that may affect lipid metabolism
* Consuming alcohol more than 2 drinks per day e.g., beer of 24 ounces, wine of 10 ounces, and distilled spirits of 3 ounces
* Regularly consuming probiotic products and cannot stop consuming them
* Having histories of diabetes, chronic liver diseases, chronic kidney diseases, cardiovascular diseases, cancer, anemia, irritable bowel syndrome, ulcerative colitis, or anaphylaxis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT07009756
Study Brief:
Protocol Section:
NCT07009756