Effect of a culturally adapted heart-healthy diet with phytosterols and/or krill oil on lipid-related outcomes in familial hypercholesterolaemia: protocol for a multicentre randomised controlled trial in Brazil.
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de Abreu-Silva Erlon Oliveira, Vieira Machado Rachel H, El Khouri Fernanda Jafet, Dos Santos Fabiana Borges, de Oliveira Monike A Matos, Kojima Flávia C Soares, Peron Roger A Novaes, Machado Lucas Simoes, Malvezzi Gisele C de Souza, Rodrigues Leticia Barbante, Veiga Thabata Silva, Negrelli Karina do Lago, de Barros E Silva Pedro G M, Santos Renato H Nakagawa, Bersch-Ferreira Ângela C, Carvalho Adriana Bastos, de Oliveira Thaís Martins, Izar Maria Cristina, Sampaio Geni Rodrigues, Damasceno Nagila R Teixeira, Rogero Marcelo Macedo, Torres Elizabeth A Ferraz da Silva, de Luca Patrícia Vieira, Batista Fernanda A Heleno, Cavalcanti Alexandre Biasi, Marcadenti Aline
Аннотация
METHODS AND ANALYSIS: The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.
ETHICS AND DISSEMINATION: This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.
TRIAL REGISTRATION NUMBER: NCT06331195.