Evaluating a Brazilian diet and supplements for familial hypercholesterolemia

Effects of an Adapted Brazilian Cardioprotective Diet Supplemented or Not with Phytosterols And/or Krill Oil in Patients with Familial Hypercholesterolemia: the DICA-FH Randomized Clinical Trial

This study is testing whether a special Brazilian diet with added supplements can help people with familial hypercholesterolemia lower their cholesterol and improve heart health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Hospital do Coracao (other)
• Drugs / interventions: alirocumab, evolocumab
• Locations: 1 site (São Paulo)
• Trial ID: NCT06331195 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effects of an adapted Brazilian Cardioprotective Diet, supplemented with phytosterols and krill oil, on patients diagnosed with familial hypercholesterolemia. Participants will be randomly assigned to one of four groups, including a control group receiving placebos. The study will also explore the impact of these interventions on lipid profiles, adherence rates, and the prevalence of subclinical atherosclerosis. Whole genome sequencing and pharmacogenomic analysis will be conducted to further understand the participants' responses.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 16 and older with a definitive or probable diagnosis of familial hypercholesterolemia.

Not a fit: Patients with a possible diagnosis of familial hypercholesterolemia or those with triglyceride levels above 500 mg/dL may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary approach to managing familial hypercholesterolemia, potentially improving patient outcomes.

How similar studies have performed: While dietary interventions for cholesterol management have been explored, this specific combination of diet and supplements in familial hypercholesterolemia is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥16 years;
* Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
* Using one of the following treatment regimens for ≥6 weeks according to age:

\>= 20 years -\> simvastatin 40 mg; lovastatin 40 mg; pravastatin 80 mg; atorvastatin 20 mg; rosuvastatin 10 mg; pitavastatin 4 mg; fluvastatin 80 mg; atorvastatin 40- 80 mg; rosuvastatin 20 - 40 mg; atorvastatin 40 - 80 mg + ezetimibe 10mg; rosuvastatin 20 - 40 mg + ezetimibe 10mg; or simvastatin 40mg + ezetimibe 10mg.

16 to 19 years -\> simvastatin 10 - 40 mg; lovastatin 10 - 40 mg; pravastatin 10 - 40 mg; atorvastatin 10 - 40 mg; rosuvastatin 5 - 40 mg; cholestyramine 4 to 16 mg; ezetimibe 10mg (in combination with statin).

Exclusion Criteria:

* Having a "possible" FH result according to the Dutch MEDPED criteria;
* TG ≥ 500mg/dL up to 6 months before screening for the study;
* Diagnosis of hypercholesterolemia due to a secondary cause recorded in the medical record;
* Food allergies (foods, dyes, preservatives);
* Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
* HIV positive on treatment with detectable viral load or AIDS;
* Chronic inflammatory or autoimmune diseases;
* Known liver disease, chronic kidney disease on dialysis or pancreatitis (acute and chronic);
* Cancer being treated or life expectancy \< 6 months;
* Episode of acute coronary syndrome in the last 60 days;
* Chemical dependency/alcoholism;
* Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
* Use of PCSK9 inhibitors (alirocumab, evolocumab, inclisiran);
* Pregnancy or lactation;
* Individuals who are unable to perform an anthropometric assessment, at the discretion of the investigator;
* Grade III/severe obesity (body mass index \[BMI\] ≥40kg/m² for adults or percentile \>99.9 or z-score \>+3 according to WHO/2006 growth curves for BMI/Age indicator for adolescents);
* Use of dietary supplements that may interfere with the outcomes of interest (dietary fiber modules, n-3 PUFA, essential fatty acids);
* Participation in other randomized clinical trials;
* Refusal to participate in the study, due to failure to sign the Free and Informed Consent Form.

Where this trial is running

São Paulo

• Hcor — São Paulo, Brazil (RECRUITING)

Study contacts

• Principal investigator: Aline Marcadenti, PhD — Hospital do Coracao
• Study coordinator: Aline Marcadenti, PhD

Conditions: Familial Hypercholesterolemia