Non-Alcoholic Fatty Liver Disease Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Kathleen E Corey, MD/MPH
kathleen.corey@mgh.harvard.edu
6177265925
Backup
Jenna Gustafson, MS
JLGustafson@mgh.harvard.edu
6177243836
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 25
Treatments
Experimental: Time-Restricted, Intermittent Fasting Group
Special type of diet for 6 weeks, called time-restricted, intermittent fasting.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov