NCT05695937Completed
Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia
Effect of the Adapted Brazilian Cardioprotective Diet Supplemented With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: DICA-HF Pilot Study
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 13 Jan 2023
- Start date
- 22 May 2023
- Primary completion date
- 29 Dec 2023
- Lead sponsor
- Hospital do Coracao
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05695937
What you commit to
- Study type: Interventional
- Participants enrolled: 58
- From 22 May 2023 to the primary completion date, 29 Dec 2023
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of anti-inflammatory, anticonvulsant and immunosuppressive drugs;
- Use of PCSK9 inhibitors (alirocumab and evolocumab);
Other illness
- Diagnosis of hypercholesterolemia due to a secondary cause (hypothyroidism, nephrotic syndrome, etc.);
- Food allergies (food, dyes, preservatives);
- 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;
Other
- "Possible" diagnosis of FH according to the Dutch MEDPED criteria;
- Fasting triglycerides ≥ 500mg/dL;
- Contraindication to the use of phytosterols (for example: diagnosis of sitosterolemia);
- Chemical dependency/alcoholism;
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Sao Jose Coordinator of this site? Confirm its status | Criciúma | Brazil | Unknown status |
| Hospital das Clinicas da Universidade Federal de Goias Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Universidade Regional do Noroeste do Estado do Rio Grande do Sul Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Instituto Nacional de Cardiologia Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Hospital Ana Nery Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Universidade Feevale Coordinator of this site? Confirm its status | São Leopoldo | Brazil | Unknown status |
| Hcor Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto Dante Pazzanese de Cardiologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| INCOR Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.