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An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)
Sponsor: Hospital do Coracao
Summary
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.
Official title: Effects of an Adapted Brazilian Cardioprotective Diet Supplemented or Not With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: the DICA-FH Randomized Clinical Trial
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-10-23
Completion Date
2026-12
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
Placebo phytosterol
Placebo of phytosterol, in the same quantity of the active phytosterol.
Placebo krill oil
Placebo of krill oil, in the same quantity of the active krill oil.
Phytosterol
2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.
Krill oil
2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.
Locations (24)
Hcor
São Paulo, São Paulo, Brazil
OCARA
Belém, Brazil
Centro Oncológico de Roraima
Boa Vista, Brazil
Instituto de Cardiologia e Transplantes do DF
Brasília, Brazil
Universidade do Mato Grosso do Sul
Campo Grande, Brazil
Universidade Federal do Mato Grosso
Cuiabá, Brazil
Hospital Oto Aldeota
Fortaleza, Brazil
Universidade Federal de Goiás
Goiânia, Brazil
Universidade Federal do Amapá
Macapá, Brazil
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió, Brazil
Universidade Federal do Amazonas
Manaus, Brazil
Universidade Estadual de Maringá
Maringá, Brazil
Santa Casa de Montes Claros
Montes Claros, Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas
Natal, Brazil
Universidade Federal do Tocantins
Palmas, Brazil
Universidade Federal do Vale do São Francisco
Petrolina, Brazil
Instituto de Pesquisa e Ensino em Saúde
Porto Velho, Brazil
Centro de Pesquisa Silvestre Santé
Rio Branco, Brazil
Instituto Nacional de Cardiologia
Rio de Janeiro, Brazil
Hospital Ana Nery
Salvador, Brazil
InCor
São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Universidade Federal de São Paulo
São Paulo, Brazil
Centro de Pesquisa Cardiolima
Teresina, Brazil