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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01353820
Eligibility Criteria:
Inclusion Criteria:
* male and female aged 18-75 years;
* BMI between 19 and 30 kg/m2,
* LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy,
* stabilized hypercholesterolemia (since more than 3 months),
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
* used to consume dairy products,
* for female: effective contraceptive methods used,
* agreeing to a written informed consent
Exclusion Criteria:
* plasma triglycerides (TG) levels \> 350 mg/dL (4 mmol//L),
* any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months,
* known allergy or hypersensitivity to milk proteins,
* systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria,
* subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
* diabetic subjects (type I and type II),
* any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
* for female subject: pregnancy, breast feeding or intention to become pregnant during the study,
* for female subject: subject likely to change her contraceptive method during the study,
* active heavy cigarette smokers (reported more than 20 cigarettes / day),
* subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01353820
Study Brief:
Protocol Section:
NCT01353820