Could a 3-Day diet reshape the Liver's fat and genes?

NCT ID NCT05965973

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This pilot study tests whether eating a low-carbohydrate, high-unsaturated-fat diet for three days can alter the liver's fat composition and the activity of genes linked to fat metabolism, inflammation, and scarring in people with pre-diabetes. Participants will follow either this diet or a low-fat diet under carefully controlled conditions. The goal is to understand how replacing carbs with unsaturated fats might affect liver health, potentially offering a dietary strategy for fatty liver disease.

What this could mean

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

Active substance
A low-carbohydrate, high-unsaturated-fat diet compared with a low-fat diet
What this could lead to
If this diet changes liver fat and gene activity in a beneficial way, it could point toward a dietary approach to prevent or manage fatty liver disease in people at risk.
What could go wrong
This is a very small pilot study (6 people) over just 3 days, so results may not apply broadly. It only looks at short-term changes, not long-term health outcomes.

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

6 people

The number who actually took part.

Started

Jun 2023

Finished

Jul 2026

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

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: * Males and females 18 to 60 years of age. * Non-smoker * Waist circumference \> 102 cm for men and \> 88 cm for women. * Plasma triglyceride levels \> 1,7 mmol/L at the screening visit. * Fasting plasma glucose levels \> 6,1 mmol/L at the screening visit. * Fasting plasma insulin levels above the upper limit of normal at the screening visit. * Subjects must be willing to give written informed consent and able to adhere to the diet schedule and visit schedule. * Patients should be otherwise healthy, without abnormal renal function or coagulation. Exclusion Criteria: * Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded. * Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.). * Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study. * Individuals with a history of mental instability, drug or alcohol abuse within the past 2 years or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study. * Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation. * Known impairment of renal function (creatinine \>2.0 mg/dL), dysproteinemia, nephrotic syndrome, or other renal disease. * Subjects with coagulopathy (prothrombin time \[PT\] or partial thromboplastin time \[PTT\] at Visit 1 higher than 1.5 times control). * Patients who are known to have tested positive for human immunodeficiency virus (HIV). * Patients who have used any investigational drug within 30 days of the first clinic visit. * Diabetic patients are excluded from the study. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Institute of Nutrition and Functional Foods (INAF)

    Québec, Quebec, G1V 0A6, Canada

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