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; 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.
DICA-FH study is a superiority, factorial, and in parallel multicenter randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 20 center sites in different Brazilian geographic regions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Placebo of phytosterol, in the same quantity of the active phytosterol.
Placebo of krill oil, in the same quantity of the active krill oil.
2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.
2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.
Hcor
São Paulo, São Paulo, Brazil
RECRUITINGOCARA
Belém, Brazil
RECRUITINGCentro Oncológico de Roraima
Boa Vista, Brazil
RECRUITINGInstituto de Cardiologia e Transplantes do DF
Brasília, Brazil
RECRUITINGUniversidade do Mato Grosso do Sul
Campo Grande, Brazil
RECRUITINGUniversidade Federal do Mato Grosso
Cuiabá, Brazil
RECRUITINGHospital Oto Aldeota
Fortaleza, Brazil
RECRUITINGUniversidade Federal de Goiás
Goiânia, Brazil
RECRUITINGUniversidade Federal do Amapá
Macapá, Brazil
RECRUITINGCentro de Pesquisas Clínicas Dr. Marco Mota
Maceió, Brazil
RECRUITING...and 14 more locations
LDL-c
Low-density lipoprotein cholesterol, in mg/dL
Time frame: 120 days
Lp(a)
Lipoprotein(a), in mg/dL
Time frame: 120 days
TC
Total cholesterol, in mg/dL
Time frame: 120 days
HDL-c
High density lipoprotein cholesterol, in mg/dL
Time frame: 120 days
TG
Fasting triglycerides, in mg/dL
Time frame: 120 days
VLDL
Very low-density lipoprotein cholesterol, in mg/dL
Time frame: 120 days
NHDL
Non-HDL cholesterol, in mg/dL, calculated according to the mathematical formula: CT - HDL-c
Time frame: 120 days
CI I
Castelli Index I, in mg/dL, calculated according to the mathematical formula: CT/HDL-c
Time frame: 120 days
CI II
Castelli Index II, in mg/dL, calculated according to the mathematical formula: LDL-c/HDL-c
Time frame: 120 days
TG/HDL-c
TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c
Time frame: 120 days
AI
Atherogenic index, in mg/dL, calculated according to the mathematical formula: NHDL/HDL-c
Time frame: 120 days
ox-LDL
Oxidized LDL, in µg/mL
Time frame: 120 days
APOAI
Apolipoprotein A-I, in mg/dL
Time frame: 120 days
APOB100
Apolipoprotein B-100, in mg/dL
Time frame: 120 days
AE
Adverse events (mild, moderate and severe), registered as percentage per study group
Time frame: 120 days
Adherence
Adherence to treatment, evaluated by: attendance at consultations (at least 3 of the 4 planned study visits); diet quality; plasma concentrations of phytosterols and erythrocyte levels of EPA/DHA fatty acids (identified by the difference between the last and the first study visits); and counting the consumed products under investigation (consumption of at least 80% of the capsules provided to the participants, regardless of the allocation group).
Time frame: 120 days
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