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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06894251
Eligibility Criteria:
Inclusion Criteria:
* For women
* If pre-menopausal: effective non-estrogenic contraception established for at least 2 cycles, to be maintained during the study,
* If menopausal: without estrogenic Hormone Replacement Therapy (HRT)
* LDL cholesterol \>1.3 g/L (according to Friedewald calculation);
* Having stable eating habits, a level of physical activity and a weight for at least 3 months before the start of the study;
* Agreeing to maintain their lifestyle habits throughout the duration of the study;
* Agreeing to follow the constraints generated by the study;
* Having signed the informed consent form;
* Social security insured.
Exclusion Criteria:
* Subjects receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.)
* Subjects presenting triglyceridemia \> 4g/L (Friedewald)
* Subject requiring immediate treatment with statin
* Subject requiring immediate dietary intervention or having fluctuating eating behavior
* Diabetic subjects treated or not with medication
* Subjects with unstable treatment (for less than three months), or requiring the implementation of treatment during the study which, according to the investigator, could interfere with the evaluation of the study criteria (efficacy: LDL, TG, HDL, blood sugar, blood pressure, weight; safety: markers of liver, muscle or kidney function)
* Subjects who have consumed in the last 3 months food supplements or functional foods that could impact cholesterol or TG levels (phytosterol, phytostanol, red yeast rice, policosanols, beta-glucans at a dose greater than 3 g/day, probiotics)
* Subjects suffering from a severe chronic condition deemed incompatible with the study by the investigator (serious digestive pathologies, renal failure, coronary pathology, immunodeficiency, heart failure, rhythm disorders, progressive tumor pathology, blood disease)
* Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating disorder)
* Pregnant woman or planning to become pregnant during the study period or breastfeeding
* Whose state of health or concomitant treatments are judged by the principal investigator or a qualified co-investigator to be incompatible with the proper conduct of the clinical study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06894251
Study Brief:
Protocol Section:
NCT06894251