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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02990260
Eligibility Criteria:
Inclusion Criteria:
* Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.
Exclusion Criteria:
* Total cholesterol \> 3.5 g/L (on an empty stomach)
* Triglycerides \> 3 g/L (on an empty stomach)
* Familial hypercholesterolemia (IIa type)
* Diabete mellitus treated or not
* Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study
* Subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study
* Subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study
* Subjects following a low diet regimen (intakes \< 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study
* Food behaviour disorders diagnosed
* Subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery
* Subjects having endure bariatric surgery or having a gastric bypass in place
* Pregnant or lactating women
* Women willing a pregnancy Excessive alcohol consumption
* Susceptible to modify their tobacco consumption before the end of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02990260
Study Brief:
Protocol Section:
NCT02990260