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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04147767
Eligibility Criteria:
Inclusion Criteria:
1. Subjects capable of giving informed consent;
2. Non-pregnant, non-nursing female;
3. Age between 18-65 years old;
4. LDL-C ≥130mg/dL (3.4mmol/L) or TC/HDL ratio \>4;
5. BMI ≥25 (kg/m2)
Exclusion Criteria:
1. Subjects who are under treatment with lipophilic statins;
2. Subjects under any other supplementation that improve cholesterol levels (i.e. monacolin, other PSS enriched products);
3. Subjects under any weight loss or lipid lowering dietary plan;
4. Present or past chronic diseases: CVDs, cancer, know positive hepatitis B virus surface antigen (HBsAg), hepatitis C (HCV) antibody or HIV, cirrhosis, gastrointestinal disorders (i.e. irritable bowel syndrome, Crohn's disease, celiac disease, bowel control problems), kidney diseases, autoimmune diseases, endocrine disorders, metabolic diseases (i.e. diabetes type I and type II, familiar hypercholesterolemia), neurological diseases;
5. Diagnosed eating disorders according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5);
6. Past or planned within the trial period bariatric surgery;
7. Past or planned within the trial period gastrointestinal resections;
8. Corticosteroid and chronic inflammatory therapy;
9. Consumption within the preceding 8 weeks of other compounds capable of influencing cholesterol metabolism (bile acid-binding resins, ezetimibe, psyllium, fish oil supplements, soya lecithin, phytoestrogens and other PSS-fortified foods);
10. Females pregnant or females who are planning pregnancy;
11. Females breastfeeding;
12. Phytosterolemia diseases;
13. Participants with allergies to any of the substances presents in the yoghurt drink chosen for the trial: citric acid, anhydrous, sodium chloride, disodium edetate dehydrate, polysorbate 80, sodium hydroxide, Hypersensitivity to E. Coli derived proteins, nuts, peanuts, egg and soy proteins. Participants with a latex allergy are also not eligible as the inner needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex);
14. Participants with allergies to lidocaine;
15. Participation in other dietary or clinical trials.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04147767
Study Brief:
Protocol Section:
NCT04147767