An adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in familial hypercholesterolemia: A pilot study protocol

A healthy diet is one of the pillars of familial hypercholesterolemia (FH) treatment. However, the best dietary pattern and indication for specific supplementation have not been established. Our aim is to conduct a pilot study to assess the effect of an adapted cardioprotective diet with or without...

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Bibliographic Details
Published in:	Clinical nutrition open science Vol. 54; pp. 127 - 139
Main Authors:	de Abreu-Silva, Erlon Oliveira, Machado, Rachel Helena Vieira, dos Santos, Bianca Rodrigues, Kojima, Flávia Soares, Santos, Renato Hideo Nakagawa, Murizine, Gabriela Souza, Homsi, Jordana Rosa, Negrelli, Karina Leal, Barbante, Letícia Galvão, de Barros e Silva, Pedro G.M., de Lima, Andressa Gusmão, Tramujas, Lucas, Bersch-Ferreira, Ângela Cristine, Carvalho, Adriana Bastos, de Oliveira, Thaís Martins, Izar, Maria Cristina, Sampaio, Geni Rodrigues, Damasceno, Nágila Raquel Teixeira, Rogero, Marcelo Macedo, da Silva Torres, Elizabeth Aparecida Ferraz, Costa, Rosana Perim, de Souza Mota, Luís Gustavo, Krey, Julia Pinheiro, da Silva, Lucas Ribeiro, de Luca, Patrícia Vieira, Amaral, Cristiane Kovacs, de Oliveira, Patricia Rodrigues, da Silva, Renata Alves, Moreira, Priscila, dos Santos, Elisa Maia, de Melo, Rodrigo Morel Vieira, Lima, Eduardo Gomes, de Luca, André, Heck, Thiago Gomes, Carvalho, Ana Paula Perillo Ferreira, Garofallo, Silvia Bueno, Cavalcanti, Alexandre Biasi, Marcadenti, Aline
Format:	Journal Article
Language:	English
Published:	Elsevier Ltd 01-04-2024 Elsevier
Subjects:	Diet Fatty acids Healthy Hypercholesterolemia Omega-3 Phytosterols Hypercholesterolemia Omega-3 Diet Fatty acids Healthy Phytosterols
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Summary:	A healthy diet is one of the pillars of familial hypercholesterolemia (FH) treatment. However, the best dietary pattern and indication for specific supplementation have not been established. Our aim is to conduct a pilot study to assess the effect of an adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in participants with a probable or definitive diagnosis of FH, treated with moderate/high potency statins. A national, multicenter, factorial, and parallel placebo-controlled randomized clinical trial with a superiority design and 1:1:1:1 allocation rate will be conducted. The participants will undergo whole exome sequencing and be allocated into four treatment groups: 1) a cardioprotective diet adapted for FH (DICA-FH) + phytosterol placebo + krill oil placebo; 2) DICA-FH + phytosterol 2 g/day + krill oil placebo; 3) DICA-FH + phytosterol placebo + krill oil 2 g/day; or 4) DICA-FH + phytosterol 2 g/day + krill oil 2 g/day. The primary outcomes will be low-density lipoprotein (LDL)-cholesterol and lipoprotein (a) levels and adherence to treatment after a 120-day follow-up. LDL- and high-density lipoprotein (HDL)-cholesterol subclasses, untargeted lipidomics analysis, adverse events, and protocol implementation components will also be assessed. A total of 58 participants were enrolled between May–August 2023. After the end of the follow-up period, the efficacy and feasibility results of this pilot study will form the basis of the design of a large-scale randomized clinical trial. This study's overall goal is to recommend dietary treatment strategies in the context of FH.
ISSN:	2667-2685 2667-2685
DOI:	10.1016/j.nutos.2024.01.005