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Liquid diet could shrink fatty liver without surgery

NCT ID NCT04861571

Disease control Sponsor: University of Iowa 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a very low-calorie diet (800-960 calories per day) can reduce fat and scarring in the liver for people with obesity and non-alcoholic fatty liver disease (NAFLD). Twenty participants will follow either the low-calorie diet or a standard lower-calorie diet for 8 weeks. The goal is to see if this diet can be a safe, effective option for those who cannot or do not want weight-loss surgery.

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 20 people

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

Started

Oct 2023

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

18 to 70 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 and Exclusion Criteria The inclusion criteria for participation are as follows: 1. Male and female subjects with age ≥ 18 years old and \< 70 years old. 2. BMI ≥ 30 kg/m2 and ≤ 50 kg/m2 3. Negative tests for viral hepatitis C (hepatitis C antibody) and autoimmune hepatitis (anti-smooth muscle antibody) 4. Evidence of liver steatosis on an image method such as ultrasound, CT scan or MRI, or subjects with elastography score F1 and above and/or S1 and above can be included The exclusion criteria are as follows: 1. Type 1 diabetes mellitus 2. Subjects with type 2 diabetes mellitus who use insulin 3. Heart failure 4. Myocardial infarction within last 6 months 5. Unstable angina 6. Chronic kidney disease with eGFR ≤ 30 mL/min/1.73 m² 7. Chronic obstructive pulmonary disease requiring O2 supplementation 8. Coexisting liver disease or end-stage liver disease 9. Severe or uncontrolled mental health disease, including eating disorders 10. Gout 11. History of uric acid nephrolithiasis 12. Porphyria 13. Conception attempts, confirmed pregnancy or breast feeding 14. Past or active cholecystitis without cholecystectomy 15. Uncontrolled hyperthyroidism 16. Uncontrolled hypothyroidism with TSH ≥ 10 mcIU/mL 17. Excessive alcohol consumption (that is, an AUDIT-C score ≥ 4 for men and ≥ 3 for women) 18. Use of warfarin, lithium, chronic use of prednisone (20mg or more daily) 19. Subjects with no elastography in the previous 12 months will be excluded from the study 20. Subjects with F0 and S0 on elastography will be excluded

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease obesity disorder

As listed by the trial registrant

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

NAFLD

Contacts and locations

Locations

  • University of Iowa Health Care

    Iowa City, Iowa, 52242, United States

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