Familial HypercholesterolemiaDICA-HFNCT05695937

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

A study testing phytosterol and krill oil in people with Familial Hypercholesterolemia, run by Hospital do Coracao at 9 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
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: 58 participants
Where: 9 sitesBrazil
Study dates: 22 May 2023to 30 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

"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;

Show all 19Show fewer

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Brazil9 sites

Hospital São José
Criciúma
Hospital das Clínicas da Universidade Federal de Goiás
Goiânia
Universidade Regional do Noroeste do Estado do Rio Grande do Sul
Ijuí
Instituto Nacional de Cardiologia
Rio de Janeiro
Hospital Ana Nery
Salvador
Universidade Feevale
São Leopoldo
Hcor
São Paulo
InCor
São Paulo
Instituto Dante Pazzanese de Cardiologia
São Paulo

Other trials in Brazil

About this study

Official title: Effect of the Adapted Brazilian Cardioprotective Diet Supplemented With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: DICA-HF Pilot Study

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

Read the detailed description

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: Familial Hypercholesterolemia
Being tested: phytosterol, krill oil, Placebo phytosterol, Placebo 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.

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.
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

Study groups in NCT05695937
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. 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
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).
Measured: 120 days

Secondary outcomes (12)

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
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
AE
Adverse events (mild, moderate and severe), registered as percentage per study group
Measured: 120 days
Implementation
Implementation components, measured by: on-time recruitment rates; choice and adjustments of remote platform/media for center sites training; measures of participants´ engagement to interventions; and rates of loss to follow-up.
Measured: 120 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 202330 Jul 2024

First posted25 Jan 2023
Study start22 May 2023
Primary completion29 Dec 2023
Study completion30 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05695937
Sponsor's protocol ID: DICA-HF_PILOT
Acronym: DICA-HF
Status last verified: Dec 2025
First submitted: 13 Jan 2023
Last updated: 30 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia

All Familial Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of the Adapted Brazilian Cardioprotective Diet Supplemented With Phytosterols and/or Krill Oil in Patients With Familial Hypercholesterolemia: DICA-HF Pilot Study
ClinicalTrials.gov ID: NCT05695937
Acronym / sponsor ID: DICA-HF / DICA-HF_PILOT
Conditions: Familial Hypercholesterolemia
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Hospital do CoracaoUniversity, hospital or other
Collaborators: University of Sao Paulo, National Institute of Cardiology, Laranjeiras, Brazil
Study start: 22 May 2023 (actual)
Primary completion: 29 Dec 2023 (actual)
Study completion: 30 Jul 2024 (actual)
First posted: 25 Jan 2023 (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.

World Health Organization Universal Trial Number (WHO-UTN): U1111-1296-7102

Detailed description

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-HF + placebo	Placebo comparator	Other: Placebo phytosterol, Other: Placebo krill oilParticipants 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.
DICA-HF + phytosterol	Experimental	Dietary Supplement: phytosterol, Other: Placebo krill oilParticipants 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.
DICA-HF + krill oil	Experimental	Dietary Supplement: krill oil, Other: Placebo phytosterolParticipants 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.
DICA-HF + phytosterol + krill oil	Experimental	Dietary Supplement: phytosterol, Dietary Supplement: krill oilParticipants 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.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (19 listed)

"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);

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
phytosterol2g/day will be provided to the participants, aiming to guarantee a minimum of 800mg/day of free phytosterols.	Dietary supplement	DICA-HF + 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
Placebo phytosterolPlacebo of phytosterol, in the same quantity of the active phytosterol	Other	DICA-HF + krill oil, DICA-HF + placebo
Placebo krill oilPlacebo of krill oil, in the same quantity of the active krill oil	Other	DICA-HF + phytosterol, DICA-HF + placebo

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
Adherence
Time frame: 120 days
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).

12 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
AE
Time frame: 120 days
Implementation
Time frame: 120 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Individual participant dataSharing planned: Undecided

Related trials for Familial Hypercholesterolemia

Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia

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

Adriana B Carvalho, PhD study chair

Instituto Nacional de Cardiologia

Alexandre B Cavalcanti, PhD study chair

Hospital do Coracao

9 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 9 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 3 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: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 3 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 NCT05695937.

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 30 Dec 2025.