About this trial
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
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent
Age 18 years or older at time of consent
BMI 23-30kg/m² at screening
Grade >=1 steatosis on clinical liver biopsy; OR
Disqualifiers
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)].
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]
Trial design
Single group
Treatments tested in this trial
Time-Restricted, Intermittent Fasting
BehavioralA special type of diet for 6 weeks, called time-restricted, intermittent fasting.
Treatment groups
Trial outcomes
Primary outcomes
Liver Fat Content
Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy (H-MRS)
Secondary outcomes
≥30% Relative Liver Fat Reduction Proportion
Proportion of subjects with a ≥30% relative reduction in hepatic fat
Visceral Adipose Tissue Content
Visceral Adipose Tissue Content as measured by magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS)
Quality of Life Score
Quality of Life Score as measured by Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD)
Dietary Intake
Dietary Intake as measured by caloric intake and nutrient contents, assessed by ASA24
Sponsors and contacts
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