RecruitingNot ApplicableNCT04899102

Intermittent Fasting for NAFLD in Adults

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

Sponsor

Massachusetts General Hospital

Enrollment

25 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Alcoholic Fatty Liver Disease Fatty Liver Liver Fat Fatty Liver, Nonalcoholic Intermittent Fasting

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria15

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.
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.