{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil",
        "Division of Health Care Sciences, Dresden International University, Dresden, Germany"
      ],
      "name": "Erlon Oliveira de Abreu-Silva"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Rachel H Vieira Machado"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Fernanda Jafet El Khouri"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Fabiana Borges dos Santos"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Monike A Matos de Oliveira"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Flávia C Soares Kojima"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Roger A Novaes Peron"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Lucas Simoes Machado"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Gisele C de Souza Malvezzi"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Leticia Barbante Rodrigues"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Thabata Silva Veiga"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Karina do Lago Negrelli"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil",
        "Paulista School of Medicine, Universidade Federal de São Paulo, São Paulo, Brazil"
      ],
      "name": "Pedro G M de Barros e Silva"
    },
    {
      "affiliations": [
        "Academic Research Organization, Einstein Hospital Israelita, São Paulo, Brazil"
      ],
      "name": "Renato H Nakagawa Santos"
    },
    {
      "affiliations": [
        "Department of Education and Research, Beneficencia Portuguesa de Sao Paulo, São Paulo, Brazil"
      ],
      "name": "Ângela C Bersch-Ferreira"
    },
    {
      "affiliations": [
        "Carlos Chagas Filho Biophysics Institute, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil",
        "Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil"
      ],
      "name": "Adriana Bastos Carvalho"
    },
    {
      "affiliations": [
        "Graduate Program in Genetics and Molecular Biology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil"
      ],
      "name": "Thaís Martins de Oliveira"
    },
    {
      "affiliations": [
        "Paulista School of Medicine, Universidade Federal de São Paulo, São Paulo, Brazil"
      ],
      "name": "Maria Cristina Izar"
    },
    {
      "affiliations": [
        "Department of Nutrition, School of Public Health, Universidade de São Paulo, São Paulo, Brazil"
      ],
      "name": "Geni Rodrigues Sampaio"
    },
    {
      "affiliations": [
        "Department of Nutrition, School of Public Health, Universidade de São Paulo, São Paulo, Brazil"
      ],
      "name": "Nagila R Teixeira Damasceno"
    },
    {
      "affiliations": [
        "Department of Nutrition, School of Public Health, Universidade de São Paulo, São Paulo, Brazil"
      ],
      "name": "Marcelo Macedo Rogero"
    },
    {
      "affiliations": [
        "Department of Nutrition, School of Public Health, Universidade de São Paulo, São Paulo, Brazil"
      ],
      "name": "Elizabeth A Ferraz da Silva Torres"
    },
    {
      "affiliations": [
        "Patient Author, Brazilian Association of Familial Hypercholesterolemia, São Paulo, Brazil"
      ],
      "name": "Patrícia Vieira de Luca"
    },
    {
      "affiliations": [
        "Molecular Biology Laboratory, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil"
      ],
      "name": "Fernanda A Heleno Batista"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil"
      ],
      "name": "Alexandre Biasi Cavalcanti"
    },
    {
      "affiliations": [
        "Hcor Research Institute, São Paulo, Brazil",
        "Graduate Program in Health Sciences (Cardiology), Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Su, Porto Alegre, Brazil",
        "Graduate Program in Public Health, School of Public Health, Universidade de São Paulo, São Paulo, Brazil"
      ],
      "name": "Aline Marcadenti"
    }
  ],
  "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",
  "uid": "b6766ff5-4176-59fe-90b3-e297a234a83f"
}