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

Launched by HOSPITAL DO CORACAO · Mar 19, 2024

Keywords

ClinConnect Summary

In this clinical trial, researchers are studying the effects of a special diet called the adapted Brazilian Cardioprotective Diet, along with supplements like phytosterols and krill oil, on people with familial hypercholesterolemia (FH). FH is a genetic condition that causes high cholesterol levels, which can lead to heart problems. The trial aims to see how these dietary changes and supplements affect cholesterol levels and overall heart health. It will include 300 participants aged 16 and older who have been diagnosed with FH and are already taking certain cholesterol-lowering medications.

Eligible participants will be randomly assigned to one of four groups, where they will follow the diet with different combinations of the supplements over 120 days. Researchers will track how well participants stick to the diet, any side effects they may experience, and changes in their cholesterol levels. This study is important because it could help find new ways to manage cholesterol levels in people with familial hypercholesterolemia, potentially improving heart health for many individuals. If you or a family member meet the inclusion criteria and are interested in participating, this could be an opportunity to contribute to valuable research in this area.

Gender

ALL

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.