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

NCT05695937 | Completed

• 1 other identifier: DICA-HF_PILOT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 9

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

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

• LDL-c

  Low-density lipoprotein cholesterol, in mg/dL

  120 days

• Lp(a)

  Lipoprotein(a), in mg/dL

  120 days

• Adherence

  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).

  120 days

Secondary Outcomes (12)

• TC

  120 days

• HDL-c

  120 days

• TG

  120 days

• VLDL

  120 days

• NHDL

  120 days

Other Outcomes (2)

• Subfractions

  120 days

• Lipidomics

  120 days

Study Arms (4)

DICA-HF + placebo

PLACEBO COMPARATOR

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.

Other: Placebo phytosterol; Other: Placebo krill oil

DICA-HF + phytosterol

EXPERIMENTAL

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.

Dietary Supplement: phytosterol; Other: Placebo krill oil

DICA-HF + krill oil

EXPERIMENTAL

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.

Dietary Supplement: krill oil; Other: Placebo phytosterol

DICA-HF + phytosterol + krill oil

EXPERIMENTAL

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.

Dietary Supplement: phytosterol; Dietary Supplement: krill oil

Interventions

phytosterol DIETARY_SUPPLEMENT

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

DICA-HF + phytosterol; DICA-HF + phytosterol + krill oil

krill oil 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.

DICA-HF + krill oil; DICA-HF + phytosterol + krill oil

Placebo krill oil OTHER

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

DICA-HF + phytosterol; DICA-HF + placebo

Placebo phytosterol OTHER

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

DICA-HF + krill oil; DICA-HF + placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• "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;

Sponsors & Collaborators

• Hospital do Coracao: lead
• University of Sao Paulo: collaborator
• National Institute of Cardiology, Laranjeiras, Brazil: collaborator

Study Sites (9)

Hospital São José

Criciúma, Brazil

Location

Hospital das Clínicas da Universidade Federal de Goiás

Goiânia, Brazil

Location

Universidade Regional do Noroeste do Estado do Rio Grande do Sul

Ijuí, Brazil

Location

Instituto Nacional de Cardiologia

Rio de Janeiro, Brazil

Location

Hospital Ana Nery

Salvador, Brazil

Location

Universidade Feevale

São Leopoldo, Brazil

Location

Hcor

São Paulo, Brazil

Location

InCor

São Paulo, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Officials

• Aline Marcadenti, PhD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Adriana B Carvalho, PhD

  Instituto Nacional de Cardiologia

  STUDY CHAIR

• Alexandre B Cavalcanti, PhD

  Hospital do Coracao

  STUDY CHAIR

• Angela C Bersch-Ferreira, PhD

  Real e Benemérita Associação Portuguesa de Beneficência

  STUDY CHAIR

• Elizabeth S Torres, PhD

  University of Sao Paulo

  STUDY CHAIR

• Erlon O Abreu-Silva, MSc

  Hospital do Coracao

  STUDY CHAIR

• Geni R Sampaio, PhD

  University of Sao Paulo

  STUDY CHAIR

• Julia P Krey, RDN

  Hospital do Coracao

  STUDY CHAIR

• Karina L Negrelli, DVM

  Hospital do Coracao

  STUDY CHAIR

• Luis Gustavo S Mota, RDN

  Hospital do Coracao

  STUDY CHAIR

• Marcelo M Rogero, PhD

  University of Sao Paulo

  STUDY CHAIR

• Maria Cristina Izar, PhD

  Universidade Federal de São Paulo

  STUDY CHAIR

• Nagila T Damasceno, PhD

  University of Sao Paulo

  STUDY CHAIR

• Patrícia V de Luca, MSc

  Associação Brasileira de Hipercolesterolemia Familiar

  STUDY CHAIR

• Pedro M Barros, PhD

  Hospital do Coracao

  STUDY CHAIR

• Renato N Santos, Stat

  Hospital do Coracao

  STUDY CHAIR

• Rosana Perim, MSc

  Hospital do Coracao

  STUDY CHAIR

• Thaís Martins, MD

  Hospital de Clínicas de Porto Alegre

  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: January 13, 2023
• First Posted: January 25, 2023
• Study Start: May 22, 2023
• Primary Completion: December 29, 2023
• Study Completion: July 30, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

BR (9)