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Time-Restricted eating shows promise for fatty liver disease

NCT ID NCT05332613

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests if eating only during an 8-hour window each day, along with a healthy diet and exercise, can reduce liver fat in people with non-alcoholic fatty liver disease. About 40 adults will be split into two groups: one follows the time-restricted eating plan plus standard lifestyle advice, and the other follows standard advice alone. The main goal is to see if more people in the time-restricted group achieve a 30% or greater drop in liver fat after 12 weeks.

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 40 people

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

Started

Apr 2022

Expected to finish

Dec 2030

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

18 to 65 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: * Age ≥ 18 and \< 65 years old * Must provide signed written informed consent and agree to comply with the study protocol * BMI \>25 kg/m² * Baseline liver fat content of at least 10% as measured by MRI-PDFF Exclusion Criteria: * Unclear etiology of liver disease * Competing etiologies for hepatic steatosis * Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to: * Positive hepatitis B surface antigen * Positive hepatitis C virus RNA * Suspicion of drug-induced liver disease * Alcoholic liver disease * Autoimmune hepatitis * Wilson's disease * Hemochromatosis * Primary biliary cholangitis or primary sclerosing cholangitis * Known or suspected hepatocellular carcinoma * Current or recent history (\<5 years) of significant alcohol consumption. For men, significant consumption is defined as \>30g of alcohol per day. For women, it is defined as \>20g of alcohol per day. * Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded. * Reduction in weight by ≥ 5% within the prior 90 days * Current fasting for ≥ 12 hours per day on the majority of days each week * Pregnant females * Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain * Inability to perform MRI-PDFF and/or study as defined below * Inability to medically perform prolonged fasting (i.e. insulin regimen)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

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