Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia

DICA-HF pilot study is a superiority, factorial, and in parallel randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks of varying sizes stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 9 center sites in different Brazilian geographic regions.

Inclusion criteria

• Adult participants (age ≥20 years);
• Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
• Using one of the following treatment regimens for ≥ 6 weeks: simvastatin 40 mg; lovastatin 40 mg; pravastatin 80 mg; atorvastatin 20 mg; rosuvastatin 10 mg; pitavastatin 4 mg; fluvastatin 80 mg; atorvastatin 40 - 80 mg; rosuvastatin 20 - 40 mg; atorvastatin 40 - 80 mg + ezetimibe 10mg; rosuvastatin 20 - 40 mg + ezetimibe 10mg; or simvastatin 40mg + ezetimibe 10mg.

Exclusion criteria

• "Possible" diagnosis of FH according to the Dutch MEDPED criteria;
• Fasting triglycerides ≥ 500mg/dL;
• Diagnosis of hypercholesterolemia due to a secondary cause (hypothyroidism, nephrotic syndrome, etc.);
• Food allergies (food, dyes, preservatives);
• Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
• HIV positive in treatment/AIDS;
• Chronic inflammatory diseases;
• Liver disease or chronic kidney disease on dialysis;
• Cancer under treatment or life expectancy < 6 months;
• Episode of acute coronary syndrome in the last 60 days;
• Chemical dependency/alcoholism;
• Chronic use of anti-inflammatory, anticonvulsant and immunosuppressive drugs;
• Use of PCSK9 inhibitors (alirocumab and evolocumab);
• Pregnancy or lactation;
• Wheelchair users unable to undergo anthropometric assessment;
• Body mass index ≥40kg/m²;
• Use of dietary supplements that may interfere with the outcomes of interest;
• Participation in other randomized clinical trials;
• Refusal to participate in the study.