Time-Restricted eating may tame fatty liver in lean adults
NCT ID NCT04899102
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether time-restricted intermittent fasting can lower liver fat in non-obese adults (BMI 23-30) with non-alcoholic fatty liver disease (NAFLD). Researchers will measure liver fat changes using advanced imaging and track quality of life. The goal is to find a drug-free, lifestyle-based treatment for this growing condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing and able to provide informed consent 2. Age 18 years or older at time of consent 3. BMI 23-30kg/m\^2 at screening 4. Evidence of NAFLD confirmed by historical procedure obtained no more than 6 months prior to the screening visit, defined as: * Grade \>=1 steatosis on clinical liver biopsy; OR * Fatty liver on validated imaging modality (non-contrast CT scan, MR Spectroscopy, MRI proton density fat fraction, ultrasound) 5. Liver fat fraction ≥10% on H-MRS performed during the screening period 6. Hepatitis C antibody and Hepatitis B surface antigen negative at screening Exclusion Criteria: 1. Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening \[heavy alcohol consumption is defined as: \> 20g daily for women or \> 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)\]. 2. Evidence of other known forms of chronic liver disease including: • Alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC). 3. Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting. 4. Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to the screening visit, except vitamin E. Patients on a stable dose of vitamin E can be enrolled in the study. 5. Unstable body weight \[defined as: \>10% reduction in body weight in the 6 months prior to the screening visit\] 6. Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam. 7. Current or prior history of Child-Pugh score ≥7. 8. History of liver transplant, or current placement on a liver transplant list. 9. Known positivity for human immunodeficiency virus infection. 10. Prior or planned bariatric surgery, patients on active pharmacological treatment for weight loss, or active involvement in a weight loss program. 11. Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip. 12. Chronic Kidney Disease (CKD) with eGFR \< 60. 13. For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding \[a negative urine pregnancy test is required at screening for women of child-bearing potential\]. 14. Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation. 15. Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.
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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.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ketogenic diet vs mediterranean diet: which better reshapes metabolism?
- Can a simple scan reveal hidden liver damage in diabetes patients?