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.
EO, d.A.S., RH, V.M., FJ, E.K., FB, D.S., MAM, d.O., FCS, K., RAN, P., LS, M., GCS, M., & LB, R. (2026). 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.. BMJ open. https://doi.org/10.1136/bmjopen-2026-119951
EO dAS, RH VM, FJ EK, FB DS, MAM dO, FCS K, et al. 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.. BMJ open. 2026; doi: 10.1136/bmjopen-2026-119951
EO dAS, RH VM, FJ EK, et al. 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.[J]. BMJ open. 2026. DOI: 10.1136/bmjopen-2026-119951.
@article{eo2026,
author = {de Abreu-Silva EO and Vieira Machado RH and El Khouri FJ and Dos Santos FB and de Oliveira MAM and Kojima FCS and Peron RAN and Machado LS and Malvezzi GCS and Rodrigues LB},
title = {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.},
journal = {BMJ open},
year = {2026},
doi = {10.1136/bmjopen-2026-119951},
note = {PMID: 42285576},
}
TY - JOUR AU - de Abreu-Silva EO AU - Vieira Machado RH AU - El Khouri FJ AU - Dos Santos FB AU - de Oliveira MAM AU - Kojima FCS AU - Peron RAN AU - Machado LS AU - Malvezzi GCS AU - Rodrigues LB TI - 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. T2 - BMJ open PY - 2026 DO - 10.1136/bmjopen-2026-119951 AN - PMID:42285576 ER -
INTRODUCTION: An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. 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.