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 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT01600820
Eligibility Criteria:
Inclusion Criteria:
* male and female aged 18-75 years;
* BMI between 19 and 30 kg/m2 ,
* LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
* higher than 100 mg/dl in individuals with a 10-year risk \> 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
* with or without statin monotherapy,
* willing to respect the dietary advising delivered at the screening visit,
* agreeing to a written informed consent
Exclusion Criteria:
* subject with plasma triglycerides (TG) levels \> 400 mg/dL,
* with any cardiovascular event in the last 6 months,
* subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
* diabetic (type I and type II),
* presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
* pregnant or breast feeding women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01600820
Study Brief:
Protocol Section:
NCT01600820