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.
Time-Restricted Eating (TRE) is a form of caloric restriction through daily prolonged fasting that has been shown to lead to weight loss, improved glucose regulation, and suppression of inflammation. Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. The only current treatment for MASLD is weight loss. In the proposed study, the investigators aim to test the hypothesis that TRE will add additional benefit in the treatment of MASLD on top of standard of care diet and lifestyle modifications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Participants 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).
Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
Participants 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.
Weill Cornell Medicine
New York, New York, United States
RECRUITINGPercentage 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.
Time frame: 12 weeks
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.
Time frame: Baseline, 12 weeks
Mean Change from Baseline in Weight at 12 weeks
Time frame: Baseline, 12 weeks
Mean Change from Baseline in BMI at 12 weeks
Evaluate the mean change of body mass index from baseline to 12 weeks.
Time frame: Baseline, 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.
Time frame: Baseline, 12 weeks
Mean Change from Baseline in Body Composition Measurements at 12 weeks
Evaluate the mean change of body composition measurements as measure by InBody Body
Time frame: Baseline, 12 weeks
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Mean Change from Baseline in aspartate transglutaminase at 12 weeks
Evaluate the mean change in aspartate transglutaminase from baseline to 12 weeks.
Time frame: Baseline, 12 weeks
Mean Change from Baseline in alanine transglutaminase at 12 weeks
Evaluate the mean change in alanine transglutaminase from baseline to 12 weeks.
Time frame: Baseline, 12 weeks
Mean Change from Baseline in total bilirubin at 12 weeks
Evaluate the mean change in total bilirubin from baseline to 12 weeks.
Time frame: Baseline, 12 weeks
Mean Change from Baseline in direct bilirubin at 12 weeks
Evaluate the mean change direct bilirubin from baseline to 12 weeks.
Time frame: Baseline, 12 weeks
Mean Change from Baseline in albumin at 12 weeks
Evaluate the mean change in albumin from baseline to 12 weeks.
Time frame: Baseline, 12 weeks
Mean Change from Baseline in total protein at 12 weeks
Evaluate the mean change in total protein from baseline to 12 weeks.
Time frame: Baseline, 12 weeks