NCT04899102 Intermittent Fasting for NAFLD in Adults
| NCT ID | NCT04899102 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Fatty Liver |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2022-02-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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 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.
Contact & Investigator
Kathleen Corey, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04899102 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fatty Liver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04899102 currently recruiting?
Yes, NCT04899102 is actively recruiting participants. Contact the research team at kathleen.corey@mgh.harvard.edu for enrollment information.
Where is the NCT04899102 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04899102 clinical trial?
NCT04899102 is sponsored by Massachusetts General Hospital. The principal investigator is Kathleen Corey, MD at Massachusetts General Hospital. The trial plans to enroll 25 participants.