Intermittent fasting to treat fatty liver disease in non-obese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of time-restricted, intermittent fasting on adults with non-alcoholic fatty liver disease (NAFLD) who are non-obese. NAFLD is a significant public health concern, and current treatment options are limited, particularly for those without obesity. The study aims to explore non-pharmacologic lifestyle interventions to reduce liver fat and improve metabolic health. Participants will undergo intermittent fasting to assess its efficacy in managing liver fat levels and overall health outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Kathleen Corey, MD — Massachusetts General Hospital
• Study coordinator: Kathleen E Corey, MD/MPH
• Email: kathleen.corey@mgh.harvard.edu
• Phone: 6177265925

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.