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RECRUITING
NCT06331195
NA

An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)

Sponsor: Hospital do Coracao

View on ClinicalTrials.gov

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

Interventions

OTHER

Placebo phytosterol

Placebo of phytosterol, in the same quantity of the active phytosterol.

OTHER

Placebo krill oil

Placebo of krill oil, in the same quantity of the active krill oil.

DIETARY_SUPPLEMENT

Phytosterol

2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.

DIETARY_SUPPLEMENT

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