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:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01521156
Eligibility Criteria:
Inclusion Criteria:
* Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
* Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
* Subject used to consume dairy products.
* For female subjects: effective contraceptive methods used.
* Subject having given written consent to take part in the study.
Exclusion Criteria:
* Subject with blood triglycerides levels above 350 mg/dL.
* Subject having experienced any cardiovascular event in the last 6 months.
* Subject having sitosterolemia.
* Subject taking any hypocholesterolemic treatment drugs.
* Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
* Diabetic subject (type I and type II).
* Subject smoking strictly more than 10 cigarettes / day.
* Subject with heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women).
* Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
* Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
* Subject receiving a transplant and under immunosuppressor treatment.
* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
* 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.
* Subject with 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 be pregnant during the study.
* For female subject: subject likely to change her contraceptive method during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01521156
Study Brief:
Protocol Section:
NCT01521156