Intermittent Fasting for NAFLD in Adults
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
| Condition(s) | Fatty Liver, Intermittent Fasting, Fatty Liver, Nonalcoholic, Non-Alcoholic Fatty Liver Disease, Liver Fat |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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, 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Massachusetts General Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2022-02-01 |
| NCT ID | NCT04899102 |
| Official listing | https://clinicaltrials.gov/study/NCT04899102 |