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Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Patients With Familial Hypercholesterolemia

NCT ID: NCT05695937

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DICA-HF + placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo phytosterol

Intervention Type OTHER

Placebo of phytosterol, in the same quantity of the active phytosterol

Placebo krill oil

Intervention Type OTHER

Placebo of krill oil, in the same quantity of the active krill oil

DICA-HF + 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.

Group Type EXPERIMENTAL

phytosterol

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.

Placebo krill oil

Intervention Type OTHER

Placebo of krill oil, in the same quantity of the active krill oil

DICA-HF + 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.

Group Type EXPERIMENTAL

krill oil

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.

Placebo phytosterol

Intervention Type OTHER

Placebo of phytosterol, in the same quantity of the active phytosterol

DICA-HF + phytosterol + 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.

Group Type EXPERIMENTAL

phytosterol

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.

krill oil

Intervention Type DIETARY_SUPPLEMENT

2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.

Interventions

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phytosterol

2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.

Intervention Type DIETARY_SUPPLEMENT

krill oil

2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids.

Intervention Type DIETARY_SUPPLEMENT

Placebo phytosterol

Placebo of phytosterol, in the same quantity of the active phytosterol

Intervention Type OTHER

Placebo krill oil

Placebo of krill oil, in the same quantity of the active krill oil

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* "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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role collaborator

Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aline Marcadenti, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Adriana B Carvalho, PhD

Role: STUDY_CHAIR

Instituto Nacional de Cardiologia

Alexandre B Cavalcanti, PhD

Role: STUDY_CHAIR

Hospital do Coracao

Angela C Bersch-Ferreira, PhD

Role: STUDY_CHAIR

Real e Benemérita Associação Portuguesa de Beneficência

Elizabeth S Torres, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Erlon O Abreu-Silva, MSc

Role: STUDY_CHAIR

Hospital do Coracao

Geni R Sampaio, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Julia P Krey, RDN

Role: STUDY_CHAIR

Hospital do Coracao

Karina L Negrelli, DVM

Role: STUDY_CHAIR

Hospital do Coracao

Luis Gustavo S Mota, RDN

Role: STUDY_CHAIR

Hospital do Coracao

Marcelo M Rogero, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Maria Cristina Izar, PhD

Role: STUDY_CHAIR

Universidade Federal de São Paulo

Nagila T Damasceno, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Patrícia V de Luca, MSc

Role: STUDY_CHAIR

Associação Brasileira de Hipercolesterolemia Familiar

Pedro M Barros, PhD

Role: STUDY_CHAIR

Hospital do Coracao

Renato N Santos, Stat

Role: STUDY_CHAIR

Hospital do Coracao

Rosana Perim, MSc

Role: STUDY_CHAIR

Hospital do Coracao

Thaís Martins, MD

Role: STUDY_CHAIR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital São José

Criciúma, , Brazil

Site Status

Hospital das Clínicas da Universidade Federal de Goiás

Goiânia, , Brazil

Site Status

Universidade Regional do Noroeste do Estado do Rio Grande do Sul

Ijuí, , Brazil

Site Status

Instituto Nacional de Cardiologia

Rio de Janeiro, , Brazil

Site Status

Hospital Ana Nery

Salvador, , Brazil

Site Status

Universidade Feevale

São Leopoldo, , Brazil

Site Status

Hcor

São Paulo, , Brazil

Site Status

InCor

São Paulo, , Brazil

Site Status

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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DICA-HF_PILOT

Identifier Type: -

Identifier Source: org_study_id