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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT05778656
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form.
* Age ≥18 years to ≤75 years.
* With indication to start lifestyle intervention based on recent values (e.g., last 3-6 months) of LDL-C ≥ 116 mg/dl and \< 190 mg/dl; or as long as pharmacological treatment has not been advised and started (ESC/EAS Guide, Rev Esp Cardiol. 2020).
* Access to a device (e.g., smartphone, tablet, computer) with internet and digital skills to use the website.
* Motivation and willingness to be assigned to any group to improve their diet and commitment to perform the designated protocol.
Exclusion Criteria:
* Patients with familial hypercholesterolemia and/or on treatment with lipid-lowering drugs (including statins, ezetimibe, PCSK9 inhibitors, fibrates, bile acid sequestrants, omega-3 fatty acids, nicotinic acid/Vit B3), dietary supplements or functional foods for the treatment of dyslipidemia (plant sterols, monacolin, red yeast rice, fiber supplements 3-10 g (Plantago), policosanol, berberine, and soy protein/lecithin) in the last 3 months.
* High cardiovascular risk that requires pharmacological treatment, for example, patients with recent and/or established CVD, type 1 and 2 diabetes.
* Uncompensated thyroid function disorders; relevant comorbidities (including liver failure and cholestasis, chronic kidney disease, Cushing's syndrome, nephrotic syndrome, class III obesity - BMI ≥ 40 kg/m²); cancer; psychiatric disorders and/or that in the opinion of the investigator hinder the fulfillment or follow-up of the study.
* Excessive alcohol consumption: \> 40 g/d (4 UBEs/day) in men and \> 20-25 g/d (2-2.5 UBEs/day) in women (Ministry of Health, July 2020).
* Pregnancy, lactation, perimenopause (amenorrhea \< 1 year) and women who change, start, or finish their treatment with hormonal contraceptives during the study.
* Enrollment in other research studies or following restricted eating patterns (e.g., vegetarians and vegans) that could interfere with study requirements.
* Failure to grant informed consent or not complete the initial assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05778656
Study Brief:
Protocol Section:
NCT05778656