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NCT Number: NCT05332613

Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TRE plus SOC

Behavioral

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

Behavioral

Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).

TRE

Behavioral

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 outcomes

  1. Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks

    Time frame: 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.

Secondary outcomes

  1. Mean Change from Baseline in Quality of Life Score on SF-36 at 12 weeks

    Time frame: Baseline, 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.

  2. Mean Change from Baseline in Weight at 12 weeks

    Time frame: Baseline, 12 weeks

  3. Mean Change from Baseline in BMI at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change of body mass index from baseline to 12 weeks.

  4. Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change in liver stiffness as measured by (FibroScan®) from baseline to 12 weeks.

  5. Mean Change from Baseline in Body Composition Measurements at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change of body composition measurements as measure by InBody Body

  6. Mean Change from Baseline in aspartate transglutaminase at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change in aspartate transglutaminase from baseline to 12 weeks.

  7. Mean Change from Baseline in alanine transglutaminase at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change in alanine transglutaminase from baseline to 12 weeks.

  8. Mean Change from Baseline in total bilirubin at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change in total bilirubin from baseline to 12 weeks.

  9. Mean Change from Baseline in direct bilirubin at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change direct bilirubin from baseline to 12 weeks.

  10. Mean Change from Baseline in albumin at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change in albumin from baseline to 12 weeks.

  11. Mean Change from Baseline in total protein at 12 weeks

    Time frame: Baseline, 12 weeks

    Evaluate the mean change in total protein from baseline to 12 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Lara Phipps

CONTACT

[email protected]

646-962-5483

Sonal Kumar, MD

CONTACT

[email protected]

646-962-5483

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 18, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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