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Can a brazilian diet plus supplements tame inherited high cholesterol?

NCT ID NCT06331195

Disease control Sponsor: Hospital do Coracao Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a special heart-friendly diet, with or without added plant sterols and krill oil, can improve cholesterol levels in people with familial hypercholesterolemia (a genetic condition causing very high cholesterol). About 300 participants will follow the diet and take either placebo or the supplements for 120 days. The goal is to see if these additions help lower LDL cholesterol and lipoprotein(a) better than diet alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia Hyperlipoproteinemia Type II

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Familial hypercholesterolemia

Contacts and locations

Locations

  • Centro Oncológico de Roraima

    Boa Vista, Brazil

  • Centro de Estudos e Pesquisas em Moléstias Infecciosas

    Natal, Brazil

  • Centro de Pesquisa Cardiolima

    Teresina, Brazil

  • Centro de Pesquisa Silvestre Santé

    Rio Branco, Brazil

  • Centro de Pesquisas Clínicas Dr. Marco Mota

    Maceió, Brazil

  • Hcor

    São Paulo, São Paulo, Brazil

  • Hospital Ana Nery

    Salvador, Brazil

  • Hospital Oto Aldeota

    Fortaleza, Brazil

  • InCor

    São Paulo, Brazil

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, Brazil

  • Instituto Nacional de Cardiologia

    Rio de Janeiro, Brazil

  • Instituto de Cardiologia e Transplantes do DF

    Brasília, Brazil

  • Instituto de Pesquisa e Ensino em Saúde

    Porto Velho, Brazil

  • OCARA

    Belém, Brazil

  • Santa Casa de Montes Claros

    Montes Claros, Brazil

  • Universidade Estadual de Maringá

    Maringá, Brazil

  • Universidade Federal de Goiás

    Goiânia, Brazil

  • Universidade Federal de São Paulo

    São Paulo, Brazil

  • Universidade Federal do Amapá

    Macapá, Brazil

  • Universidade Federal do Amazonas

    Manaus, Brazil

  • Universidade Federal do Mato Grosso

    Cuiabá, Brazil

  • Universidade Federal do Tocantins

    Palmas, Brazil

  • Universidade Federal do Vale do São Francisco

    Petrolina, Brazil

  • Universidade do Mato Grosso do Sul

    Campo Grande, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.