Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia
- Conditions
- Familial Hypercholesterolemia
- Interventions
- Dietary Supplement: phytosterolOther: Placebo krill oilOther: Placebo phytosterolDietary Supplement: krill oil
- Registration Number
- NCT05695937
- Lead Sponsor
- Hospital do Coracao
- Brief Summary
The main objective of this pilot study is to evaluate the effects of the 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) identified by the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ complete sequencing of the exome; to evaluate the effects of the interventions on lipid profile; to identify subclasses of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol; to perform untargeted lipidomic analyses; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; and to evaluate both implementation components and adherence rates to the protocol, aiming to design a larger randomized trial. In this pilot study, between 48 and 76 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to FH (DICA-HF) + phytosterol placebo + krill oil placebo (control group); 2) DICA-HF + 2g/day of phytosterol + krill oil placebo; 3) DICA-HF + phytosterol placebo + 2g/day of krill oil; and 4) DICA-HF + 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.
World Health Organization Universal Trial Number (WHO-UTN): U1111-1296-7102
- Detailed Description
DICA-HF pilot study is a superiority, factorial, and in parallel randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks of varying sizes stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 9 center sites in different Brazilian geographic regions.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 58
- Adult participants (age ≥20 years);
- Definitive (certainty) or probable diagnosis of FH by the Dutch MEDPED criteria;
- Using one of the following treatment regimens for ≥ 6 weeks: 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.
- "Possible" diagnosis of FH according to the Dutch MEDPED criteria;
- Fasting triglycerides ≥ 500mg/dL;
- Diagnosis of hypercholesterolemia due to a secondary cause (hypothyroidism, nephrotic syndrome, etc.);
- Food allergies (food, dyes, preservatives);
- Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
- HIV positive in treatment/AIDS;
- Chronic inflammatory diseases;
- Liver disease or chronic kidney disease on dialysis;
- Cancer under treatment or life expectancy < 6 months;
- Episode of acute coronary syndrome in the last 60 days;
- Chemical dependency/alcoholism;
- Chronic use of anti-inflammatory, anticonvulsant and immunosuppressive drugs;
- Use of PCSK9 inhibitors (alirocumab and evolocumab);
- Pregnancy or lactation;
- Wheelchair users unable to undergo anthropometric assessment;
- Body mass index ≥40kg/m²;
- Use of dietary supplements that may interfere with the outcomes of interest;
- Participation in other randomized clinical trials;
- Refusal to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description DICA-HF + phytosterol Placebo krill oil Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and placebo of the krill oil during 120 days. DICA-HF + krill oil Placebo phytosterol Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of krill oil and placebo of phytosterol during 120 days. DICA-HF + phytosterol + krill oil krill oil Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days. DICA-HF + placebo Placebo phytosterol Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus placebo of both phytosterol and krill oil during 120 days. DICA-HF + phytosterol phytosterol Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and placebo of the krill oil during 120 days. DICA-HF + krill oil krill oil Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of krill oil and placebo of phytosterol during 120 days. DICA-HF + placebo Placebo krill oil Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus placebo of both phytosterol and krill oil during 120 days. DICA-HF + phytosterol + krill oil phytosterol Participants allocated into this arm (n= 24) will receive the DICA Br adapted to FH (DICA-HF) plus 2g/day of phytosterol and 2g/day of krill oil during 120 days.
- Primary Outcome Measures
Name Time Method LDL-c 120 days Low-density lipoprotein cholesterol, in mg/dL
Lp(a) 120 days Lipoprotein(a), in mg/dL
Adherence 120 days Adherence to treatment, evaluated by: attendance at consultations (at least 3 of the 4 planned study visits); plasma concentrations of phytosterols and erythrocyte levels of EPA/DHA fatty acids (identified by the difference between the last and the first study visits); and counting the consumed products under investigation (consumption of at least 80% of the capsules provided to the participants, regardless of the allocation group).
- Secondary Outcome Measures
Name Time Method NHDL 120 days Non-HDL cholesterol, in mg/dL, calculated according to the mathematical formula: CT - HDL-c
TC 120 days Total cholesterol, in mg/dL
CI I 120 days Castelli Index I, in mg/dL, calculated according to the mathematical formula: CT/HDL-c
TG/HDL-c 120 days TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c
ox-LDL 120 days Oxidized LDL, in µg/mL
Implementation 120 days Implementation components, measured by: on-time recruitment rates; choice and adjustments of remote platform/media for center sites training; measures of participants´ engagement to interventions; and rates of loss to follow-up.
HDL-c 120 days High density lipoprotein cholesterol, in mg/dL
TG 120 days Fasting triglycerides, in mg/dL
VLDL 120 days Very low-density lipoprotein cholesterol, in mg/dL
CI II 120 days Castelli Index II, in mg/dL, calculated according to the mathematical formula: LDL-c/HDL-c
AE 120 days Adverse events (mild, moderate and severe), registered as percentage per study group
AI 120 days Atherogenic index, in mg/dL, calculated according to the mathematical formula: NHDL/HDL-c
Related Research Topics
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Trial Locations
- Locations (9)
Universidade Feevale
🇧🇷São Leopoldo, Brazil
Hospital São José
🇧🇷Criciúma, Brazil
Hospital das Clínicas da Universidade Federal de Goiás
🇧🇷Goiânia, Brazil
Universidade Regional do Noroeste do Estado do Rio Grande do Sul
🇧🇷Ijuí, Brazil
Instituto Nacional de Cardiologia
🇧🇷Rio De Janeiro, Brazil
InCor
🇧🇷São Paulo, Brazil
Hospital Ana Nery
🇧🇷Salvador, Brazil
Hcor
🇧🇷São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷São Paulo, Brazil