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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT01571869
Eligibility Criteria:
Inclusion Criteria:
* male and post-menopausal female aged 40-80 years;
* BMI between 22 and 32 kg/m2,
* Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
* Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
* Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
* Have to give written consent to take part in the study
Exclusion Criteria:
* Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95\<SBP\>140 mmHg and/or 45\<DBP\>90 mmHg),
* Previous history of symptomatic vascular disease, TG level \> 2,8 g/l,
* History of metabolic or gastrointestinal disease with the exception of appendicectomy,
* Consumption of large amounts of alcohol,
* Having undergone general anesthesia in the month prior to pre-selection,
* Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* Having serious or acute disease likely to influence study results or involved in life time,
* Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,
* Refusing to stop his/her consumption of enriched plant sterol trade products during the study,
* 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,
* For female subjects: likely to change her hormonal substitutive treatment,
* Currently in an exclusion period following participation in another clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01571869
Study Brief:
Protocol Section:
NCT01571869