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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT03850405
Eligibility Criteria:
Inclusion Criteria:
* Individuals able to fill an Informed Consent
* Aged 40-60 years old with 1:1 matched criteria, age difference of ± 1 year old
* Patients with mild dyslipidemia (total cholesterol 201-250 mg/dL, LDL≥155 mg/dL) with or without hypertriglyceridemia (150-180 mg/dL) who accept to be inserted in a program aimed to reduce their caloric intake, including diet alone or diet plus chocolate
Exclusion Criteria:
* Missing Informed Consent
* Diagnosis of organic diseases, including neoplastic inflammatory diseases or cardiovascular diseases
* Patients on statin therapy
* Drugs which can affect the gastrointestinal tract and interfere with the symptoms
* Pregnancy
* Presence of diseases with a prognosis of less than 12 months
* Hypersensitivity to chocolate or chocolate components
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT03850405
Study Brief:
Protocol Section:
NCT03850405