Intermittent Fasting for NAFLD in Adults

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 19, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of intermittent fasting as a potential treatment for non-alcoholic fatty liver disease (NAFLD) in adults who are not obese. NAFLD is a condition where excess fat builds up in the liver, and it is becoming more common among people with a normal weight. The goal of the study is to find out if changing eating patterns, like intermittent fasting, can help improve liver health for those affected by this condition.

To participate in the trial, individuals must be at least 18 years old, have a body mass index (BMI) between 23 and 30, and have been diagnosed with NAFLD through medical tests. Participants will be asked to provide informed consent and will be closely monitored throughout the study. It’s important to note that certain people, such as those with a history of heavy alcohol use, specific liver diseases, or unstable body weight, may not be eligible to join. Overall, this study aims to find non-drug ways to manage NAFLD, which could be beneficial for many people facing this health issue.

Gender

ALL

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.