Clinical trial NCT05332613: Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study
Official title: Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-site, randomized, controlled pilot study. The investigators hypothesize that time-restricted eating (TRE) will lead to an additional improvement in hepatic steatosis as compared to standard of care lifestyle recommendations alone measured by MRI-PDFF. The investigators plan to enroll 40 participants to two arms between the years of 18 and 65 with NAFLD as defined by MRI-PDFF score of greater or equal to 10%. Participants on the experimental arm (TRE plus SOC) will be required to fast for 16 hours each day for 12 weeks. Counseling will involve instructing the participant to choose an 8-hour eating window. During the fasting window, the participant is able to drink water and black coffee or tea. Participants in both arms will be given lifestyle recommendations with respect to diet and exercise. The RD will instruct participants regarding standard of care lifestyle recommendations, which includes education of a low-calorie diet and moderate-intensity exercise.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean Change from Baseline in Quality of Life Score on SF-36 at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in Weight at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in BMI at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in Body Composition Measurements at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in aspartate transglutaminase at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in alanine transglutaminase at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in total bilirubin at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in direct bilirubin at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in albumin at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Mean Change from Baseline in total protein at 12 weeks
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sonal Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: