Familial HypercholesterolemiaDICA-FHNCT06331195
An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH)
A study testing Phytosterol and Krill oil in people with Familial Hypercholesterolemia, run by Hospital do Coracao at 24 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Phytosterol and Krill oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 24 sitesBrazil
- Study dates
- 23 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 16 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).
Who cannot join
- 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;
Show all 19Show fewer
- 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;
- Grade III/severe obesity (body mass index [BMI] ≥40kg/m² for adults or percentile >99.9 or z-score >+3 according to WHO/2006 growth curves for BMI/Age indicator for adolescents);
- Use of dietary supplements that may interfere with the outcomes of interest (dietary fiber modules, n-3 PUFA, essential fatty acids);
- Participation in other randomized clinical trials;
- Refusal to participate in the study, due to failure to sign the Free and Informed Consent Form.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Brazil24 sites
OCARA
Belém
Centro Oncológico de Roraima
Boa Vista
Instituto de Cardiologia e Transplantes do DF
Brasília
Universidade do Mato Grosso do Sul
Campo Grande
Universidade Federal do Mato Grosso
Cuiabá
Hospital Oto Aldeota
Fortaleza
Universidade Federal de Goiás
Goiânia
Universidade Federal do Amapá
Macapá
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió
Universidade Federal do Amazonas
Manaus
Universidade Estadual de Maringá
Maringá
Santa Casa de Montes Claros
Montes Claros
Centro de Estudos e Pesquisas em Moléstias Infecciosas
Natal
Universidade Federal do Tocantins
Palmas
Universidade Federal do Vale do São Francisco
Petrolina
Instituto de Pesquisa e Ensino em Saúde
Porto Velho
Centro de Pesquisa Silvestre Santé
Rio Branco
Instituto Nacional de Cardiologia
Rio de Janeiro
Hospital Ana Nery
Salvador
Hcor
São Paulo, São Paulo
InCor
São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo
Universidade Federal de São Paulo
São Paulo
Centro de Pesquisa Cardiolima
Teresina
About this study
Official title: Effects of an Adapted Brazilian Cardioprotective Diet Supplemented or Not With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: the DICA-FH Randomized Clinical Trial
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.
Read the detailed description
DICA-FH study is a superiority, factorial, and in parallel multicenter randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 20 center sites in different Brazilian geographic regions.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Placebo phytosterol, Placebo krill oil, Phytosterol, Krill oil
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo phytosterolOther
Placebo of phytosterol, in the same quantity of the active phytosterol.
Placebo krill oilOther
Placebo of krill oil, in the same quantity of the active krill oil.
PhytosterolDietary supplement
2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Placebo phytosterol; Other: 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. Receives: Other: Placebo krill oil; Dietary 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. Receives: Other: Placebo phytosterol; Dietary 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. Receives: Dietary Supplement: Phytosterol; Dietary Supplement: Krill oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-c
Low-density lipoprotein cholesterol, in mg/dL
Measured: 120 days
Lp(a)
Lipoprotein(a), in mg/dL
Measured: 120 days
Secondary outcomes (14)
TC
Total cholesterol, in mg/dL
Measured: 120 days
HDL-c
High density lipoprotein cholesterol, in mg/dL
Measured: 120 days
TG
Fasting triglycerides, in mg/dL
Measured: 120 days
VLDL
Very low-density lipoprotein cholesterol, in mg/dL
Measured: 120 days
NHDL
Non-HDL cholesterol, in mg/dL, calculated according to the mathematical formula: CT - HDL-c
Measured: 120 days
CI I
Castelli Index I, in mg/dL, calculated according to the mathematical formula: CT/HDL-c
Measured: 120 days
CI II
Castelli Index II, in mg/dL, calculated according to the mathematical formula: LDL-c/HDL-c
Measured: 120 days
TG/HDL-c
TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c TG/HDL-c ratio, in mg/dL, calculated according to the mathematical formula: TG/HDL-c
Measured: 120 days
AI
Atherogenic index, in mg/dL, calculated according to the mathematical formula: NHDL/HDL-c
Measured: 120 days
ox-LDL
Oxidized LDL, in µg/mL
Measured: 120 days
APOAI
Apolipoprotein A-I, in mg/dL
Measured: 120 days
APOB100
Apolipoprotein B-100, in mg/dL
Measured: 120 days
AE
Adverse events (mild, moderate and severe), registered as percentage per study group
Measured: 120 days
Adherence
Adherence to treatment, evaluated by: attendance at consultations (at least 3 of the 4 planned study visits); diet quality; 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).
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start23 Oct 2024
- Primary completion13 Feb 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Aline Marcadenti, PhD, Principal investigator, Hospital do CoracaoRachel Helena Machado, MSc, Study chair, Hospital do CoracaoErlon O Abreu-Silva, MSc, Study chair, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331195
- Sponsor's protocol ID
- DICA-HF_MAIN
- Acronym
- DICA-FH
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting the findings of the DICA-FH study will be available upon reasonable request. Broader public access to the study database will be provided in due course, as soon as possible, in accordance with the Hcor Research Institute (IP-Hcor) data-sharing policy.
Publications
de Abreu-Silva EO, Vieira Machado RH, El Khouri FJ, Dos Santos FB, de Oliveira MAM, Kojima FCS, Peron RAN, Machado LS, Malvezzi GCS, Rodrigues LB, Veiga TS, Negrelli KDL, de Barros E Silva PGM, Santos RHN, Bersch-Ferreira AC, Carvalho AB, de Oliveira TM, Izar MC, Sampaio GR, Damasceno NRT, Rogero MM, Torres EAFDS, de Luca PV, Batista FAH, Cavalcanti AB, Marcadenti A. Effect of a culturally adapted heart-healthy diet with phytosterols and/or krill oil on lipid-related outcomes in familial hypercholesterolaemia: protocol for a multicentre randomised controlled trial in Brazil. BMJ Open. 2026 Jun 12;16(6):e119951. doi: 10.1136/bmjopen-2026-119951.
PubMed 42285576
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Adapted Brazilian Cardioprotective Diet Supplemented or Not With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: the DICA-FH Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06331195
- Acronym / sponsor ID
- DICA-FH / DICA-HF_MAIN
- Conditions
- Familial Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DICA-FH study is a superiority, factorial, and in parallel multicenter randomized placebo-controlled (double-dummy) clinical trial. The randomization will be in blocks stratified by research center, and the allocation ratio will be 1:1:1:1. Participants will come from at least 20 center sites in different Brazilian geographic regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DICA-FH + placebo | Placebo comparator | Other: Placebo phytosterol, Other: Placebo krill oilParticipants 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. |
| DICA-FH + phytosterol | Experimental | Other: Placebo krill oil, Dietary Supplement: PhytosterolParticipants 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. |
| DICA-HF + krill oil | Experimental | Other: Placebo phytosterol, Dietary Supplement: Krill oilParticipants 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. |
| DICA-HF + phytosterol + krill oil | Experimental | Dietary Supplement: Phytosterol, Dietary Supplement: Krill oilParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 16 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).
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo phytosterolPlacebo of phytosterol, in the same quantity of the active phytosterol. | Other | DICA-FH + placebo, DICA-HF + krill oil |
| Placebo krill oilPlacebo of krill oil, in the same quantity of the active krill oil. | Other | DICA-FH + phytosterol, DICA-FH + placebo |
| Phytosterol2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols. | Dietary supplement | DICA-FH + phytosterol, DICA-HF + phytosterol + krill oil |
| Krill oil2g/day will be provided to the participants, aiming to guarantee a minimum of 400mg/day of eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids. | Dietary supplement | DICA-HF + krill oil, DICA-HF + phytosterol + krill oil |
Primary outcome
LDL-c
Time frame: 120 days
Low-density lipoprotein cholesterol, in mg/dL
Lp(a)
Time frame: 120 days
Lipoprotein(a), in mg/dL
14 secondary outcomes
TC
Time frame: 120 days
HDL-c
Time frame: 120 days
TG
Time frame: 120 days
VLDL
Time frame: 120 days
NHDL
Time frame: 120 days
CI I
Time frame: 120 days
CI II
Time frame: 120 days
TG/HDL-c
Time frame: 120 days
AI
Time frame: 120 days
ox-LDL
Time frame: 120 days
APOAI
Time frame: 120 days
APOB100
Time frame: 120 days
AE
Time frame: 120 days
Adherence
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 42285576de Abreu-Silva EO, Vieira Machado RH, El Khouri FJ, Dos Santos FB, de Oliveira MAM, Kojima FCS, Peron RAN, Machado LS, Malvezzi GCS, Rodrigues LB, Veiga TS, Negrelli KDL, de Barros E Silva PGM, Santos RHN, Bersch-Ferreira AC, Carvalho AB, de Oliveira TM, Izar MC, Sampaio GR, Damasceno NRT, Rogero MM, Torres EAFDS, de Luca PV, Batista FAH, Cavalcanti AB, Marcadenti A. Effect of a culturally adapted heart-healthy diet with phytosterols and/or krill oil on lipid-related outcomes in familial hypercholesterolaemia: protocol for a multicentre randomised controlled trial in Brazil. BMJ Open. 2026 Jun 12;16(6):e119951. doi: 10.1136/bmjopen-2026-119951.
- Individual participant dataSharing planned: Yes. The data supporting the findings of the DICA-FH study will be available upon reasonable request. Broader public access to the study database will be provided in due course, as soon as possible, in accordance with the Hcor Research Institute (IP-Hcor) data-sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline Marcadenti, PhD principal investigator
Hospital do Coracao
Rachel Helena Machado, MSc study chair
Hospital do Coracao
Erlon O Abreu-Silva, MSc study chair
Hospital do Coracao
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytosterol and Krill oil in people with Familial Hypercholesterolemia, run by Hospital do Coracao at 24 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-c (time frame: 120 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06331195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.