Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TRE plus SOC, SOC, TRE.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study
Overview
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. 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.
Interventions
- 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). - Behavioral SOC
Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes). - Behavioral 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.
Primary outcome measures
- Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks [Time frame: 12 weeks]
Secondary outcome measures (11)
- Mean Change from Baseline in Quality of Life Score on SF-36 at 12 weeks [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 [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in Body Composition Measurements at 12 weeks [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in aspartate transglutaminase at 12 weeks [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in alanine transglutaminase at 12 weeks [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in total bilirubin at 12 weeks [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in direct bilirubin at 12 weeks [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in albumin at 12 weeks [Time frame: Baseline, 12 weeks]
- Mean Change from Baseline in total protein at 12 weeks [Time frame: Baseline, 12 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT05332613 · 21-10024103