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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT06490133
Eligibility Criteria:
Inclusion Criteria:
* BMI between 25 and 35 Kg/m2
* Total Cholesterol levels in peripheral blood above or equal to 200 mg/dL or LDL-cholesterol levels above or equal to 160 mg/dL.
* Weight stability during the three months prior the start of the study (±5% of variation).
* To be able to attend the visits and accomplish with all the indications of the research staff.
* To have signed the written informed consent.
Exclusion Criteria:
* Any alteration of the Gastrointestinal system, functional or structural (gastric ulcer, chronic inflammatory diseases, hernia, etc.)
* Subjects having undergone any surgical operation in th egastrointestinal tract with permanent consequences (i.e. gastroduodenectomy).
* Subjects following any pharmacological treatment affecting gastric homeostasis.
* Suffer from any metabolic disease or cancer process.
* Being allergic to any of the compounds contained in the study capsules.
* Excessive alcohol ingestion (14 units/day for women, or 20 units/day for men).
* Women lactating or during pregnancy.
* Following any cholesterol-lowering treatment.
* People with any mental impairment or whose compliance with the study protocol is at risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06490133
Study Brief:
Protocol Section:
NCT06490133