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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT06481020
Eligibility Criteria:
Inclusion Criteria:
* BMI: 27-29.9 or 30-39.9
* Plasmatic glucose: \< 100mg/dl or 100-125mg/dl
* Glycosylated hemoglobin: \< 5.7 or 5.7-6.4
* LDL cholesterol \> 115mg/dL
* Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.
Exclusion Criteria:
* Subjects on cholesterol-lowering pharmacological treatment
* Smokers
* Alcohol consumption above 30 g/day
* Pregnant or lactating women
* Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)
* Diseases of the gastrointestinal tract
* Antibiotic, hormonal or anabolic treatment
* Participants consuming foods enriched with PS or food supplements that contain PS
* Participants who follow specialist weight loss diets, vegans or vegetarians
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06481020
Study Brief:
Protocol Section:
NCT06481020