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

Hospital do Coracao

Status: Enrolling

Conditions: Familial Hypercholesterolemia

Treatments: Other: Placebo krill oil; Dietary Supplement: Phytosterol; Other: Placebo phytosterol; Dietary Supplement: Krill oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06331195

DICA-HF_MAIN

Details and patient eligibility

About

The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil. Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up.

Full description

DICA-FH study is a superiority, factorial, and in parallel multicenter randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 20 center sites in different Brazilian geographic regions.

Enrollment: 300 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

DICA-FH + placebo

Placebo Comparator group

Description:

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus placebo of both phytosterol and krill oil during 120 days.

Treatment:

Other: Placebo phytosterol

Other: Placebo krill oil

DICA-FH + phytosterol

Experimental group

Description:

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and placebo of the krill oil during 120 days.

Treatment:

Dietary Supplement: Phytosterol

Other: Placebo krill oil

DICA-HF + krill oil

Experimental group

Description:

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of krill oil and placebo of phytosterol during 120 days.

Treatment:

Dietary Supplement: Krill oil

Other: Placebo phytosterol

DICA-HF + phytosterol + krill oil

Experimental group

Description:

Participants allocated into this arm (n= 75) will receive the DICA Br adapted to FH (DICA-FH) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.

Treatment:

Dietary Supplement: Krill oil

Dietary Supplement: Phytosterol