protocolSection identificationModule nctId: NCT06331195, orgStudyIdInfo id: DICA-HF_MAIN, briefTitle: An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH), acronym: DICA-FH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hospital do Coracao, class: OTHER, collaborators name: University of Sao Paulo, collaborators name: National Institute of Cardiology, Laranjeiras, Brazil, collaborators name: Instituto Dante Pazzanese de Cardiologia, descriptionModule briefSummary: The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; to identify the prevalence of subclinical atherosclerosis; to perform pharmacogenomic analysis; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil.Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up., conditionsModule conditions: Familial Hypercholesterolemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Placebo phytosterol, interventions name: Placebo krill oil, interventions name: Phytosterol, interventions name: Krill oil, outcomesModule primaryOutcomes measure: LDL-c, primaryOutcomes measure: Lp(a), secondaryOutcomes measure: TC, secondaryOutcomes measure: HDL-c, secondaryOutcomes measure: TG, secondaryOutcomes measure: VLDL, secondaryOutcomes measure: NHDL, secondaryOutcomes measure: CI I, secondaryOutcomes measure: CI II, secondaryOutcomes measure: TG/HDL-c, secondaryOutcomes measure: AI, secondaryOutcomes measure: ox-LDL, secondaryOutcomes measure: APOAI, secondaryOutcomes measure: APOB100, secondaryOutcomes measure: AE, secondaryOutcomes measure: Adherence, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False