brazilian cardioprotective diet, phytosterols and krill oil in patients with familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: the main objective of this pilot study is to evaluate the effects of the 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) identified by the dutch lipid clinic network (dutch medped) criteria. in addition, the following will be considered secondary objectives: to perform participants´ complete sequencing of the exome; to evaluate the effects of the interventions on lipid profile; to identify subclasses of low-density lipoprotein (ldl) and high-density lipoprotein (hdl) cholesterol; to perform untargeted lipidomic analyses; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate both implementation components and adherence rates to the protocol, aiming to design a larger randomized trial. in this pilot study, between 48 and 76 individuals will be randomly enrolled into four groups: 1) dica br adapted to fh (dica-hf) + phytosterol placebo + krill oil placebo (control group); 2) dica-hf + 2g/day of phytosterol + krill oil placebo; 3) dica-hf + phytosterol placebo + 2g/day of krill oil; and 4) dica-hf + 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. world health organization universal trial number (who-utn): u1111-1296-7102

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.

Eligibility criteria:
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.