Status:
RECRUITING
Intermittent Fasting for NAFLD in Adults
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Fatty Liver
Intermittent Fasting
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD. Non-obese NAFLD (BMI\<30kg/m2) is an increasingly recognized condition, so...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD), which encompasses a spectrum from simple steatosis and steatohepatitis (NASH) to fibrosis and cirrhosis, is the leading cause of liver disease in the United S...
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent
- Age 18 years or older at time of consent
- BMI 23-30kg/m\^2 at screening
- 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)
- Liver fat fraction ≥10% on H-MRS performed during the screening period
- Hepatitis C antibody and Hepatitis B surface antigen negative at screening
Exclusion
- Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening \[heavy alcohol consumption is defined as: \> 20g daily for women or \> 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)\].
- 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).
- Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
- 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.
- Unstable body weight \[defined as: \>10% reduction in body weight in the 6 months prior to the screening visit\]
- Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam.
- Current or prior history of Child-Pugh score ≥7.
- History of liver transplant, or current placement on a liver transplant list.
- Known positivity for human immunodeficiency virus infection.
- Prior or planned bariatric surgery, patients on active pharmacological treatment for weight loss, or active involvement in a weight loss program.
- Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip.
- Chronic Kidney Disease (CKD) with eGFR \< 60.
- For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding \[a negative urine pregnancy test is required at screening for women of child-bearing potential\].
- Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation.
- Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04899102
Start Date
February 1 2022
End Date
July 31 2026
Last Update
December 18 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114