Tiny trial tests if diet can undo fatty liver in Low-Birth-Weight adults

NCT ID NCT05842850

Knowledge-focused Sponsor: Steno Diabetes Center Copenhagen Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a 4-week low-calorie diet can reverse fatty liver disease in people who were born with low birth weight. Researchers will compare them to people born at normal weight, using MRI scans to measure liver fat before and after the diet. Only 8 participants are being enrolled, making this a very early, small-scale investigation.

What this could mean

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

Active substance: low-calorie diet (meal replacement)
What this could lead to: If successful, this could show that fatty liver linked to low birth weight can be reversed with diet, pointing toward targeted lifestyle interventions.
What could go wrong: This is a very small, early proof-of-principle study with only 8 participants. Results may not apply to the broader population, and the diet is short-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

About 8 people

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

Started

Jan 2026

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

35 to 40 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: * subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study) Exclusion Criteria: * BMI\<18.5 and BMI\>30 kg/m2 * Family history of diabetes (siblings, parent, and grandparents) * Disease/medication known to affect primary outcome * Self-reported high physical activity level * Alcohol intake above general recommendations. * Metabolic/liver disease * Weight gain/loss of \>3 kg within the past 6 months

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Conditions

The condition(s) this trial relates to.

Insulin Resistance metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

NAFLD

How to take part

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

The places running it

2 sites. The list below names each one and where it is.
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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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Tiny trial tests if diet can undo fatty liver in Low-Birth-Weight adults

What the study statuses mean