Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia

Summary

The main objective of this pilot study is to evaluate the effects of the 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) identified by the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ complete sequencing of the exome; to evaluate the effects of the interventions on lipid profile; to identify subclasses of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol; to perform untargeted lipidomic analyses; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate both implementation components and adherence rates to the protocol, aiming to design a larger randomized trial. In this pilot study, between 48 and 76 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to FH (DICA-HF) + phytosterol placebo + krill oil placebo (control group); 2) DICA-HF + 2g/day of phytosterol + krill oil placebo; 3) DICA-HF + phytosterol placebo + 2g/day of krill oil; and 4) DICA-HF + 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.

World Health Organization Universal Trial Number (WHO-UTN): U1111-1296-7102

Conditions

• Familial Hypercholesterolemia

Interventions

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.

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

Sponsors & Collaborators

• University of Sao Paulo

  collaborator OTHER

• National Institute of Cardiology, Laranjeiras, Brazil

  collaborator OTHER_GOV

• Hospital do Coracao

  lead OTHER

Principal Investigators

• Aline Marcadenti, PhD · Hospital do Coracao

• Adriana B Carvalho, PhD · Instituto Nacional de Cardiologia

• Alexandre B Cavalcanti, PhD · Hospital do Coracao

• Angela C Bersch-Ferreira, PhD · Real e Benemérita Associação Portuguesa de Beneficência

• Elizabeth S Torres, PhD · University of Sao Paulo

• Erlon O Abreu-Silva, MSc · Hospital do Coracao

• Geni R Sampaio, PhD · University of Sao Paulo

• Julia P Krey, RDN · Hospital do Coracao

• Karina L Negrelli, DVM · Hospital do Coracao

• Luis Gustavo S Mota, RDN · Hospital do Coracao

• Marcelo M Rogero, PhD · University of Sao Paulo

• Maria Cristina Izar, PhD · Universidade Federal de São Paulo

• Nagila T Damasceno, PhD · University of Sao Paulo

• Patrícia V de Luca, MSc · Associação Brasileira de Hipercolesterolemia Familiar

• Pedro M Barros, PhD · Hospital do Coracao

• Renato N Santos, Stat · Hospital do Coracao

• Rosana Perim, MSc · Hospital do Coracao

• Thaís Martins, MD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-22

Primary Completion

2023-12-29

Completion

2024-07-30

Countries

• Brazil

Study Locations