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

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.

Conditions

• Familial Hypercholesterolemia

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.

Sponsors & Collaborators

• University of Sao Paulo

  collaborator OTHER

• Hospital do Coracao

  lead OTHER

Principal Investigators

• Aline Marcadenti, PhD · Hospital do Coracao

• Rachel Helena Machado, MSc · Hospital do Coracao

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-23

Primary Completion

2026-02-13

Completion

2026-12-31

Countries

• Brazil

Study Locations