Actively Recruiting
Intermittent Fasting for NAFLD in Adults
Led by Massachusetts General Hospital · Updated on 2025-12-18
25
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, sometimes described as "lean NAFLD". Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. The purpose of this study is to identify non-pharmacologic, lifestyle-based methods of NAFLD treatment within non-obese adults.
CONDITIONS
Official Title
Intermittent Fasting for NAFLD in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Age 18 years or older at time of consent
- BMI between 23 and 30 kg/m² at screening
- Evidence of NAFLD confirmed by liver biopsy or validated imaging within 6 months prior to screening
- Liver fat fraction of at least 10% on H-MRS during screening
- Negative for Hepatitis C antibody and Hepatitis B surface antigen at screening
You will not qualify if you...
- Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening (more than 20g daily for women or more than 30mg daily for men)
- Other chronic liver diseases such as alcoholic liver disease, hepatitis B or C, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, or known/suspected liver cancer
- Current or past Type II Diabetes requiring insulin or sulfonylureas
- Use of pharmacologic treatments for NAFLD/NASH within 6 months prior to screening, except stable vitamin E use
- Unstable body weight defined as more than 10% reduction in the past 6 months
- Known cirrhosis or advanced liver fibrosis, or clinical evidence of cirrhosis or portal hypertension
- History of Child-Pugh score 7 or higher
- History of liver transplant or currently listed for liver transplant
- Known HIV infection
- Prior or planned bariatric surgery or active weight loss treatment or program
- MRI exclusion criteria like pacemaker or cerebral aneurysm clip
- Chronic kidney disease with eGFR less than 60
- For women of childbearing potential: positive pregnancy test, trying to become pregnant, or breastfeeding
- Other medical conditions or severe illnesses that may interfere with study participation
- Any condition that may hinder compliance or completion of study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
K
Kathleen E Corey, MD/MPH
CONTACT
J
Jenna Gustafson, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here