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Plant-Based diet may lower cholesterol in genetic heart condition

NCT ID NCT05181553

Knowledge-focused Sponsor: Laval University 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a whole-food plant-based diet, compared to a standard North American diet, can lower LDL cholesterol in 50 adults with heterozygous familial hypercholesterolemia (HeFH). Participants followed each diet for 28 days in a crossover design. Researchers also looked for metabolic markers of healthy eating.

What this could mean

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

Active substance
whole-food plant-based diet
What this could lead to
If successful, this could show that a plant-based diet helps lower cholesterol in people with familial hypercholesterolemia and provide a way to measure diet adherence.
What could go wrong
This is a small, completed study (50 participants) that looks at short-term effects only. Results may not apply to everyone with the condition.

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

50 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 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

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Genetically-defined HeFH * Premenopausal women with a regular menstrual cycle for \>3 months * Postmenopausal women (without hormone replacement) Exclusion criteria: * Any cardiovascular disease-risk exacerbating conditions (age \>60 years, homozygous FH, personal history of cardiovascular disease, diabetes/anti-diabetic drug use, severe obesity, unstable body weight for \>3 months, uncontrolled hypertension, genetic hypertriglyceridemia), * Allergies/aversions to components of the experimental diets * Any condition that would interfere with optimal participation in the intervention.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder cholesterol metabolism disease familial hypercholesterolemia Hypercholesterolemia hyperlipidemia Hyperlipoproteinemia Type II metabolic disease

As listed by the trial registrant

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

Cardiovascular diseases Cholesterol, elevated Cholesterol; metabolic disorder Familial hypercholesterolemia Nutrition, healthy

Contacts and locations

Locations

  • Institute on nutrition and functional foods, Laval University

    Québec, Quebec, G1V0A6, Canada

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