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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01521169
Eligibility Criteria:
Inclusion Criteria:
1. Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL.
2. Subject aged from 20 to 65 years (bounds included)
3. Subject with BMI between 19 - 30 kg/m² (bounds included)
4. Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
5. Non diabetic subjects (BS≤125 mg/dL)
6. Non hypertensive subjects (SBP\<140mmHg and DBP\<90 mmHg)
7. Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
8. Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
9. Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study
Exclusion Criteria:
1. Subject currently involved in a clinical trial.
2. Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
3. Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study.
4. For female subject: pregnancy or intention to be pregnant during the study.
5. For female subject: breast feeding.
6. Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
7. Subject having lactose intolerance.
8. Subjects having sitosterolemia
9. Diabetic subject (Type I and type II)
10. Subject with heavy alcohol intake (\>60g/day)
11. Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
12. Subject receiving a transplant or under immunosuppressor treatment
13. Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
14. Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months
15. Subject deemed unsuitable by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01521169
Study Brief:
Protocol Section:
NCT01521169