Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332613
• Other study ID #: 21-10024103
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: Sonal Kumar, MD
• Phone: 646-962-5483
• Email: sok9028[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Non-alcoholic fatty liver disease (NAFLD) is a metabolic condition that in certain patients can lead to significant morbidity and mortality. The only current treatment for NAFLD is weight loss. In the proposed study, the investigators aim to test the hypothesis that TRE will add additional benefit in the treatment of NAFLD on top of standard of care diet and lifestyle modifications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unclear etiology of liver disease

• Competing etiologies for hepatic steatosis

• Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:

• Positive hepatitis B surface antigen

• Positive hepatitis C virus RNA

• Suspicion of drug-induced liver disease

• Alcoholic liver disease

• Autoimmune hepatitis

• Wilson's disease

• Hemochromatosis

• Primary biliary cholangitis or primary sclerosing cholangitis

• Known or suspected hepatocellular carcinoma

• Current or recent history (<5 years) of significant alcohol consumption. For men, significant consumption is defined as >30g of alcohol per day. For women, it is defined as >20g of alcohol per day.

• Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded.

• Reduction in weight by = 5% within the prior 90 days

• Current fasting for = 12 hours per day on the majority of days each week

• Pregnant females

• Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain

• Inability to perform MRI-PDFF and/or study as defined below

• Inability to medically perform prolonged fasting (i.e. insulin regimen)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Behavioral:
• TRE plus SOC
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).
• SOC
Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
• TRE
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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks	Evaluate the percentage of patients with baseline NAFLD (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.	12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	Mean Change from Baseline in Weight at 12 weeks		Baseline, 12 weeks
Secondary	Mean Change from Baseline in BMI at 12 weeks	Evaluate the mean change of body mass index from baseline to 12 weeks.	Baseline, 12 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	Mean Change from Baseline in Body Composition Measurements at 12 weeks	Evaluate the mean change of body composition measurements as measure by InBody Body	Baseline, 12 weeks
Secondary	Mean Change from Baseline in aspartate transglutaminase at 12 weeks	Evaluate the mean change in aspartate transglutaminase from baseline to 12 weeks.	Baseline, 12 weeks
Secondary	Mean Change from Baseline in alanine transglutaminase at 12 weeks	Evaluate the mean change in alanine transglutaminase from baseline to 12 weeks.	Baseline, 12 weeks
Secondary	Mean Change from Baseline in total bilirubin at 12 weeks	Evaluate the mean change in total bilirubin from baseline to 12 weeks.	Baseline, 12 weeks
Secondary	Mean Change from Baseline in direct bilirubin at 12 weeks	Evaluate the mean change direct bilirubin from baseline to 12 weeks.	Baseline, 12 weeks
Secondary	Mean Change from Baseline in albumin at 12 weeks	Evaluate the mean change in albumin from baseline to 12 weeks.	Baseline, 12 weeks
Secondary	Mean Change from Baseline in total protein at 12 weeks	Evaluate the mean change in total protein from baseline to 12 weeks.	Baseline, 12 weeks