An adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in familial hypercholesterolemia: A pilot study protocol
Clinical Nutrition Open Science
; 24: 127-139, abr.2024. ilus, tab
Article
in English
| CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1537510
Responsible library:
BR79.1
ABSTRACT
BACKGROUND AND AIMS:
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.METHODS:
A national, multicenter, factorial, and parallel placebocontrolled randomized clinical trial with a superiority design and 1111 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 (DICAFH) þ phytosterol placebo þ krill oil placebo; 2) DICA-FH þ phytosterol 2 g/day þ krill oil placebo; 3) DICA-FH þ phytosterol placebo þ krill oil 2 g/day; or 4) DICA-FH þ phytosterol 2 g/day þ 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.RESULTS:
A total of 58 participants were enrolled between May e 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.CONCLUSIONS:
This study's overall goal is to recommend dietary treatment strategies in the context of FH.
Full text:
Available
Collection:
National databases
/
Brazil
Database:
CONASS
/
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Main subject:
Hyperlipoproteinemia Type II
Language:
English
Journal:
Clinical Nutrition Open Science
Year:
2024
Document type:
Article
Institution/Affiliation country:
Beneficência Portuguesa de São Paulo/BR
/
Brazilian Association of Familial Hypercholesterolemia/BR
/
Dante Pazzanese Institute of Cardiology/BR
/
Dasa Cardiology Unit (Hospital 9 de Julho)/BR
/
Federal University of Bahia/BR
/
Federal University of Goias/BR
/
Federal University of Rio Grande do Sul/BR
/
Federal University of Rio de Janeiro/BR
/
Federal University of São Paulo/BR
/
Feevale University/BR