Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can plant sterols and krill oil tame inherited high cholesterol?

NCT ID NCT05695937

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

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tested whether adding plant sterols (phytosterols) and/or krill oil to a heart-healthy Brazilian diet can lower cholesterol in people with familial hypercholesterolemia (FH), an inherited condition causing very high cholesterol. Fifty-eight adults with FH were randomly assigned to one of four groups: diet alone, diet plus phytosterols, diet plus krill oil, or diet plus both supplements. The study measured changes in LDL cholesterol and lipoprotein(a) after 120 days, along with adherence and side effects, to inform a larger future trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
phytosterols and krill oil (dietary supplements)
What this could lead to
If it works, this could point toward a way to better manage high cholesterol in people with familial hypercholesterolemia using diet and supplements.
What could go wrong
This is a small pilot study (58 people) with no phase, so results are preliminary. The supplements may not significantly lower cholesterol, and the diet may be hard to stick with long-term.

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

58 people

The number who actually took part.

Started

May 2023

Finished

Jul 2024

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

20 to 80 years

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: * 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. Exclusion Criteria: * "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; * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Familial hypercholesterolemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Hcor

    São Paulo, Brazil

  • Hospital Ana Nery

    Salvador, Brazil

  • Hospital São José

    Criciúma, Brazil

  • Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, Brazil

  • InCor

    São Paulo, Brazil

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, Brazil

  • Instituto Nacional de Cardiologia

    Rio de Janeiro, Brazil

  • Universidade Feevale

    São Leopoldo, Brazil

  • Universidade Regional do Noroeste do Estado do Rio Grande do Sul

    Ijuí, Brazil

More trials for these conditions

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