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

Pilot Study of Time-Restricted, Intermittent Fasting for Non-Alcoholic Fatty Liver Disease in Non-Obese Adults

This study is testing if intermittent fasting can help non-obese adults with fatty liver disease improve their liver health and overall well-being.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04899102 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI between 23-30 kg/m² and confirmed NAFLD.

Not a fit: Patients with significant alcohol use or other chronic liver diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive, lifestyle-based treatment option for patients with non-obese NAFLD.

How similar studies have performed: While intermittent fasting has shown promise in various health contexts, this specific application for non-obese NAFLD is relatively novel and underexplored.

Eligibility criteria

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 this trial is running

Boston, Massachusetts

• 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

Conditions: Fatty Liver, Intermittent Fasting, Fatty Liver, Nonalcoholic, Non-Alcoholic Fatty Liver Disease, Liver Fat, Non-obese, Diet, Nutrition