NCT06331195

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

24 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 23, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 19, 2024

Last Update Submit

April 22, 2026

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • LDL-c

    Low-density lipoprotein cholesterol, in mg/dL

    120 days

  • Lp(a)

    Lipoprotein(a), in mg/dL

    120 days

Secondary Outcomes (14)

  • TC

    120 days

  • HDL-c

    120 days

  • TG

    120 days

  • VLDL

    120 days

  • NHDL

    120 days

  • +9 more secondary outcomes

Study Arms (4)

DICA-FH + placebo

PLACEBO COMPARATOR

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.

Other: Placebo phytosterolOther: Placebo krill oil

DICA-FH + phytosterol

EXPERIMENTAL

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.

Other: Placebo krill oilDietary Supplement: Phytosterol

DICA-HF + krill oil

EXPERIMENTAL

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.

Other: Placebo phytosterolDietary Supplement: Krill oil

DICA-HF + phytosterol + krill oil

EXPERIMENTAL

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.

Dietary Supplement: PhytosterolDietary Supplement: Krill oil

Interventions

Placebo phytosterolOTHER

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

DICA-FH + placeboDICA-HF + krill oil
Placebo krill oilOTHER

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

DICA-FH + phytosterolDICA-FH + placebo
PhytosterolDIETARY_SUPPLEMENT

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

DICA-FH + phytosterolDICA-HF + phytosterol + krill oil
Krill oilDIETARY_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.

DICA-HF + krill oilDICA-HF + phytosterol + krill oil

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Hcor

São Paulo, São Paulo, Brazil

Location

OCARA

Belém, Brazil

Location

Centro Oncológico de Roraima

Boa Vista, Brazil

Location

Instituto de Cardiologia e Transplantes do DF

Brasília, Brazil

Location

Universidade do Mato Grosso do Sul

Campo Grande, Brazil

Location

Universidade Federal do Mato Grosso

Cuiabá, Brazil

Location

Hospital Oto Aldeota

Fortaleza, Brazil

Location

Universidade Federal de Goiás

Goiânia, Brazil

Location

Universidade Federal do Amapá

Macapá, Brazil

Location

Centro de Pesquisas Clínicas Dr. Marco Mota

Maceió, Brazil

Location

Universidade Federal do Amazonas

Manaus, Brazil

Location

Universidade Estadual de Maringá

Maringá, Brazil

Location

Santa Casa de Montes Claros

Montes Claros, Brazil

Location

Centro de Estudos e Pesquisas em Moléstias Infecciosas

Natal, Brazil

Location

Universidade Federal do Tocantins

Palmas, Brazil

Location

Universidade Federal do Vale do São Francisco

Petrolina, Brazil

Location

Instituto de Pesquisa e Ensino em Saúde

Porto Velho, Brazil

Location

Centro de Pesquisa Silvestre Santé

Rio Branco, Brazil

Location

Instituto Nacional de Cardiologia

Rio de Janeiro, Brazil

Location

Hospital Ana Nery

Salvador, Brazil

Location

InCor

São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Universidade Federal de São Paulo

São Paulo, Brazil

Location

Centro de Pesquisa Cardiolima

Teresina, Brazil

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Officials

  • Aline Marcadenti, PhD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

  • Rachel Helena Machado, MSc

    Hospital do Coracao

    STUDY CHAIR

  • Erlon O Abreu-Silva, MSc

    Hospital do Coracao

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

October 23, 2024

Primary Completion

February 13, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

BR(24)