Non-Alcoholic Fatty Liver DiseaseNCT05332613
Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease
A study testing TRE plus SOC, SOC and TRE in people with Non-Alcoholic Fatty Liver Disease, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- TRE plus SOC, SOC and TRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Sonal Kumar, MD, 6469625483, sok9028@med.cornell.edu
Lara Phipps, 6469625483, lap4015@med.cornell.edu
About this study
Official title: Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- TRE plus SOC, SOC, TRE
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRE plus SOCBehavioural
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).
SOCBehavioural
Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
TREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TRE plus SOC | Experimental | Participants will be required to fast each day for 12 weeks and will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. The RD will collect the participant's normal diet and exercise routine. Counseling will involve instructing the participant to choose an eight-hour eating window (e.g., 10:00am - 6:00pm) during which the participant will be able to eat. During the 16-house fasting window (e.g., 6:00pm - 10:00 am), the participant is able to drink regular water and black coffee or tea. The RD will be available to answer any questions the participants may have pertaining to the regimen and will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise. Receives: Behavioral: TRE plus SOC |
| SOC | Active comparator | lifestyle modifications and weight management. Participants will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. A baseline dietary record will be assessed prior to fasting initiation with the RD in person. The RD will also collect the subject's normal diet and exercise routine. The RD will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise. Receives: Behavioral: SOC |
| Crossover to TRE | Experimental | Participants who have not lost weight or have lost less than or equal to 5% of their body weight, they will be given the option to crossover to the TRE arm. Following the initial 12-week period and end of study MRI, participants would restart another identical 12-week cycle but adhering to the exact steps of the TRE arm including another 4 visits with the registered dieticians (RDs) and an end of study visit with repeat Fibroscan, InBody 770 body composition scan, and MRI-PDFF. Receives: Behavioral: TRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage 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.
Measured: 12 weeks
Secondary outcomes (11)
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.
Measured: Baseline, 12 weeks
Mean Change from Baseline in Weight at 12 weeks
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 12 weeks
Mean Change from Baseline in aspartate transglutaminase at 12 weeks
Evaluate the mean change in aspartate transglutaminase from baseline to 12 weeks.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks
Mean Change from Baseline in direct bilirubin at 12 weeks
Evaluate the mean change direct bilirubin from baseline to 12 weeks.
Measured: Baseline, 12 weeks
Mean Change from Baseline in albumin at 12 weeks
Evaluate the mean change in albumin from baseline to 12 weeks.
Measured: 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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start27 Apr 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 MASLD 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonal Kumar, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332613
- Sponsor's protocol ID
- 21-10024103
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT05332613
- Acronym / sponsor ID
- 21-10024103
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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 MASLD 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.
| Arm | Type | Receives |
|---|---|---|
| TRE plus SOC | Experimental | Behavioral: TRE plus SOCParticipants will be required to fast each day for 12 weeks and will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. The RD will collect the participant's normal diet and exercise routine. Counseling will involve instructing the participant to choose an eight-hour eating window (e.g., 10:00am - 6:00pm) during which the participant will be able to eat. During the 16-house fasting window (e.g., 6:00pm - 10:00 am), the participant is able to drink regular water and black coffee or tea. The RD will be available to answer any questions the participants may have pertaining to the regimen and will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise. |
| SOC | Active comparator | Behavioral: SOClifestyle modifications and weight management. Participants will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. A baseline dietary record will be assessed prior to fasting initiation with the RD in person. The RD will also collect the subject's normal diet and exercise routine. The RD will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise. |
| Crossover to TRE | Experimental | Behavioral: TREParticipants who have not lost weight or have lost less than or equal to 5% of their body weight, they will be given the option to crossover to the TRE arm. Following the initial 12-week period and end of study MRI, participants would restart another identical 12-week cycle but adhering to the exact steps of the TRE arm including another 4 visits with the registered dieticians (RDs) and an end of study visit with repeat Fibroscan, InBody 770 body composition scan, and MRI-PDFF. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRE plus SOCParticipants 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). | Behavioural | TRE plus SOC |
| SOCParticipants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes). | Behavioural | SOC |
| TREParticipants 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. | Behavioural | Crossover to TRE |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonal Kumar, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE plus SOC, SOC and TRE in people with Non-Alcoholic Fatty Liver Disease, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonal Kumar, MD (646-962-5483, sok9028@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.