An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)

Prior treatment

• TG ≥ 500mg/dL up to 6 months before screening for the study;
• HIV positive on treatment with detectable viral load or AIDS;
• Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
• Use of PCSK9 inhibitors (alirocumab, evolocumab, inclisiran);

Other illness

• Food allergies (foods, dyes, preservatives);
• Chronic inflammatory or autoimmune diseases;
• Known liver disease, chronic kidney disease on dialysis or pancreatitis (acute and chronic);
• Cancer being treated or life expectancy \< 6 months;
• Episode of acute coronary syndrome in the last 60 days;
• Refusal to participate in the study, due to failure to sign the Free and Informed Consent Form.

Age

• Grade III/severe obesity (body mass index \[BMI\] ≥40kg/m² for adults or percentile \>99.9 or z-score \>+3 according to WHO/2006 growth curves for BMI/Age indicator for adolescents);

Other

• Having a "possible" FH result according to the Dutch MEDPED criteria;
• Diagnosis of hypercholesterolemia due to a secondary cause recorded in the medical record;
• Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
• Chemical dependency/alcoholism;
• Pregnancy or lactation;
• Individuals who are unable to perform an anthropometric assessment, at the discretion of the investigator;
• Use of dietary supplements that may interfere with the outcomes of interest (dietary fiber modules, n-3 PUFA, essential fatty acids);
• Participation in other randomized clinical trials;

• Age ≥16 years;
• Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
• Using one of the following treatment regimens for ≥6 weeks according to age:
  • \>= 20 years -\> 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.
  • 16 to 19 years -\> simvastatin 10 - 40 mg; lovastatin 10 - 40 mg; pravastatin 10 - 40 mg; atorvastatin 10 - 40 mg; rosuvastatin 5 - 40 mg; cholestyramine 4 to 16 mg; ezetimibe 10mg (in combination with statin).