This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.
Age ≥ 18 and < 65 years old
Must provide signed written informed consent and agree to comply with the study protocol
BMI >25 kg/m²
Baseline liver fat content of at least 10% as measured by MRI-PDFF
Unclear etiology of liver disease
Competing etiologies for hepatic steatosis
Positive hepatitis B surface antigen
Positive hepatitis C virus RNA
Parallel
TRE plus SOC
BehavioralParticipants will undergo time restricted eating (TRE) each day for 12 weeks and will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
SOC
BehavioralParticipants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
TRE
BehavioralParticipants will undergo time restricted eating (TRE) each day for 12 weeks plus 4 extra visits with the registered dietician and repeat Fibroscan, InBody composition scan, and MRI-PDFF.
Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks
Evaluate the percentage of patients with baseline MASLD (MRI-PDFF greater than or equal to 10%) who achieve clinically significant improvement in hepatic fat, as defined by greater than or equal to 30% reduction from baseline liver fat on MRI-PDFF, while adopting a time-restricted eating pattern (fasting 16 hours per day) along with standard of care management as compared to patients with only standard of care NAFLD management.
Mean Change from Baseline in Quality of Life Score on SF-36 at 12 weeks
Evaluate the mean change of quality of life score from SF-36 from baseline to 12 weeks. Scores range from 0-100. Higher scores indicate better health status, while lower scores indicate a poorer health status. A mean score of 50 has been articulated as the normative value of all scales.
Mean Change from Baseline in Weight at 12 weeks
Mean Change from Baseline in BMI at 12 weeks
Evaluate the mean change of body mass index from baseline to 12 weeks.
Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks
Evaluate the mean change in liver stiffness as measured by (FibroScan®) from baseline to 12 weeks.
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