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
Clinical Snapshot
PICO Framework
| P — Population | Individuals aged ≥16 years with probable or definite familial hypercholesterolaemia according to Dutch Lipid Clinic Network criteria, receiving age-appropriate lipid-lowering therapy |
| I — Intervention | Brazilian Cardioprotective Diet (DICA-FH) adapted from Portfolio Diet with phytosterol 2g/day and/or krill oil 2g/day supplementation |
| C — Comparator | DICA-FH diet with placebo supplements (phytosterol placebo and krill oil placebo) |
| O — Outcomes | Primary: LDL cholesterol and lipoprotein(a) levels at 120 days. Secondary: additional lipid biomarkers, adherence, adverse events |
Bottom Line
This protocol describes a well-designed factorial RCT examining whether adding phytosterols and/or krill oil to a culturally adapted cardioprotective diet provides additional lipid benefits in familial hypercholesterolaemia patients. The study addresses an important clinical question using rigorous methodology including placebo controls and genetic screening. However, as a protocol paper, the actual clinical effectiveness cannot be assessed. The 120-day timeframe may be too short to evaluate sustained dietary adherence, and the sample size may limit subgroup analyses. The culturally adapted Brazilian diet approach could inform similar interventions globally. Results will be valuable for clinicians managing FH patients seeking evidence-based dietary adjuncts to standard therapy, particularly in populations where genetic testing and personalised nutrition approaches are becoming more accessible.
Key Findings
P Value: Not available - protocol paper
Effect Size: Not available - protocol paper
Primary Outcome: LDL cholesterol and lipoprotein(a) levels at 120 days
Nnt Or Sensitivity: Not available - protocol paper
Confidence Interval: Not available - protocol paper
Clinical Application
Moderate - requires specialised dietary counselling and supplement provision, but builds on existing Portfolio Diet evidence Relevant to Australian FH patients; phytosterols available through PBS for certain indications, krill oil available as complementary medicine through TGA regulation Patients with familial hypercholesterolaemia on standard lipid-lowering therapy seeking additional dietary management strategies
Abstract
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.
References
- 1.de Abreu-Silva, E. O., Vieira Machado, R. H., El Khouri, F. J., Dos Santos, F. B., de Oliveira, M. A. M., Kojima, F. C. S., Peron, R. A. N., Machado, L. S., Malvezzi, G. C. S., Rodrigues, L. B., Veiga, T. S., Negrelli, K. L., de Barros E Silva, P. G. M., Santos, R. H. N., Bersch-Ferreira, Â. C., Carvalho, A. B., de Oliveira, T. M., Izar, M. C., Sampaio, G. R., Damasceno, N. R. T., Rogero, M. M., Torres, E. A. F. S., de Luca, P. V., Batista, F. A. H., Cavalcanti, A. B., & Marcadenti, A. (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
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