The DICA-FH study is a multicentre randomised controlled trial designed to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol (2 g/day) and/or krill oil (2 g/day) supplementation on LDL cholesterol and lipoprotein(a) levels in individuals with familial hypercholesterolaemia over 120 days.
The study targets individuals with probable or definite familial hypercholesterolaemia as defined by the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.
The trial uses a 2×2 factorial design with four parallel groups in a 1:1:1:1 allocation ratio.
The primary outcomes are mean LDL cholesterol and lipoprotein(a) levels measured after 120 days of intervention.
The planned sample size for the trial is 300 participants.
The dietary intervention is the Brazilian Cardioprotective Diet (DICA Br), which is culturally adapted from the Portfolio Diet for a Brazilian population with FH.
The study received ethical approval from multiple Brazilian regulatory bodies and is registered as a clinical trial.
The paper acknowledges that the optimal dietary pattern and the role of adjunctive nutrient supplementation for FH management remain uncertain.
This paper describes the protocol for a clinical trial called DICA-FH, which is investigating whether a heart-healthy Brazilian diet, used alone or combined with plant sterol supplements and/or krill oil, can improve cholesterol levels in people with familial hypercholesterolaemia (FH) — a genetic condition causing dangerously high LDL ('bad') cholesterol from birth. The trial will enroll 300 participants aged 16 and older across multiple Brazilian centers, randomly assigning them to one of four groups: diet alone, diet plus plant sterols (2 g/day), diet plus krill oil (2 g/day), or diet plus both supplements. All participants continue their usual cholesterol-lowering medications and undergo genetic testing. The main outcomes measured after 120 days are LDL cholesterol and lipoprotein(a) — another blood fat linked to heart disease risk. This research suggests that combining a culturally tailored, affordable diet with targeted nutritional supplements could offer an additional, accessible way to manage cholesterol in people with FH, who often struggle to reach safe cholesterol levels with medication alone. The inclusion of lipoprotein(a) as a primary outcome is notable because it is a cholesterol-related marker that is not well controlled by standard medications and is particularly elevated in some FH patients. By testing the diet and both supplements together and separately in a factorial design, the study can determine whether each component contributes independently to cholesterol reduction. The trial is relevant because FH affects approximately 1 in 250 people worldwide and significantly increases the risk of early heart disease. Dietary strategies are an important but often underexplored part of FH management, particularly in lower- and middle-income settings where expensive medications may not be fully accessible. Results from this trial, expected after July 2026, could inform dietary guidelines and supplementation recommendations specifically for Brazilian and potentially other Latin American FH populations.
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Upload Your Labsde Abreu-Silva E, Vieira Machado R, El Khouri F, Dos Santos F, de Oliveira M, Kojima F, et al.. (2026). Effect of a culturally adapted heart-healthy diet with phytosterols and/or krill oil on lipid-related outcomes in familial hypercholesterolaemia: protocol for a multicentre randomised controlled trial in Brazil.. BMJ open. https://doi.org/10.1136/bmjopen-2026-119951