Fatty LiverNCT04899102
Intermittent Fasting for NAFLD in Adults
A study testing Time-Restricted, Intermittent Fasting in people with Fatty Liver and Intermittent Fasting, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD. Non-obese NAFLD (BMI<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver, Intermittent Fasting, Fatty Liver, Nonalcoholic
- What is being tested?
- Time-Restricted, Intermittent Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent
- Age 18 years or older at time of consent
- BMI 23-30kg/m^2 at screening
- Evidence of NAFLD confirmed by historical procedure obtained no more than 6 months prior to the screening visit, defined as:
- Grade >=1 steatosis on clinical liver biopsy; OR
- Fatty liver on validated imaging modality (non-contrast CT scan, MR Spectroscopy, MRI proton density fat fraction, ultrasound)
- Liver fat fraction ≥10% on H-MRS performed during the screening period
- Hepatitis C antibody and Hepatitis B surface antigen negative at screening
Who cannot join
- Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening [heavy alcohol consumption is defined as: > 20g daily for women or > 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)].
- Evidence of other known forms of chronic liver disease including:
- Alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
- Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
- Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to the screening visit, except vitamin E. Patients on a stable dose of vitamin E can be enrolled in the study.
- Unstable body weight [defined as: >10% reduction in body weight in the 6 months prior to the screening visit]
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- Known cirrhosis, stage 4 fibrosis on prior liver biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam.
- Current or prior history of Child-Pugh score ≥7.
- History of liver transplant, or current placement on a liver transplant list.
- Known positivity for human immunodeficiency virus infection.
- Prior or planned bariatric surgery, patients on active pharmacological treatment for weight loss, or active involvement in a weight loss program.
- Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip.
- Chronic Kidney Disease (CKD) with eGFR < 60.
- For women of child-bearing potential (WOCBP): positive urine hCG, trying to achieve pregnancy, or breastfeeding [a negative urine pregnancy test is required at screening for women of child-bearing potential].
- Other medical conditions or severe chronic illnesses that, in the opinion of the Investigator, may present a contraindication to study participation.
- Any other condition that, in the opinion of the Investigator, may hinder study compliance or completion of the study schedule of assessments.
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kathleen E Corey, MD/MPH, 6177265925, kathleen.corey@mgh.harvard.edu
Megan Michta, BA, 6176439458, mmichta@mgh.harvard.edu
About this study
Official title: Pilot Study of Time-Restricted, Intermittent Fasting for Non-Alcoholic Fatty Liver Disease in Non-Obese Adults
NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD. Non-obese NAFLD (BMI<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. The purpose of this study is to identify non-pharmacologic, lifestyle-based methods of NAFLD treatment within non-obese adults.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD), which encompasses a spectrum from simple steatosis and steatohepatitis (NASH) to fibrosis and cirrhosis, is the leading cause of liver disease in the United States. There are currently no FDA-approved pharmacologic therapies for NAFLD and NASH, and standard low-calorie diets are often minimally effective, difficult to adhere to and to maintain. Thus, continued investigation of strategies to treat NAFLD and NASH is greatly needed. Non-obese NAFLD (BMI<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". It is estimated that 10-20% of American and Europeans without obesity have this condition. There is a pressing need for the study of lifestyle interventions independent of weight loss to treat this important subset of NAFLD patients. This protocol aims to investigate the utility of time restricted, intermittent fasting (TRF) as a potential method. Adults with non-obese NAFLD are at risk of progression to end-stage liver disease and development of cardiometabolic disease. Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. IF is characterized by periods of dietary restriction leading to metabolic production and use of ketones from adipocytes rather than hepatically-derived glucose.
The goal of this study is to learn if time-restricted, intermittent fasting can help reduce the amount of fat in the liver in adults with non-alcoholic fatty liver disease (NAFLD). Ideally, this study will yield more information about time-restricted, intermittent fasting as a potential lifestyle-based treatment for adults with NAFLD and a body mass index (BMI) between 23-30 kg/m^2.
- Conditions
- Fatty Liver, Intermittent Fasting, Fatty Liver, Nonalcoholic, Non-Alcoholic Fatty Liver Disease, Liver Fat
- Being tested
- Time-Restricted, Intermittent Fasting
- Keywords
- Fatty Liver, Intermittent Fasting, Non-obese, Diet, Nutrition, Time-restricted, Liver Fat, Non-Alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic
- Medical subject headings
- Fatty Liver, Intermittent Fasting, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted, Intermittent FastingBehavioural
A special type of diet for 6 weeks, called time-restricted, intermittent fasting.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted, Intermittent Fasting Group | Experimental | Special type of diet for 6 weeks, called time-restricted, intermittent fasting. Receives: Behavioral: Time-Restricted, Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Fat Content
Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy (H-MRS)
Measured: change from baseline to 6 weeks
Secondary outcomes (4)
≥30% Relative Liver Fat Reduction Proportion
Proportion of subjects with a ≥30% relative reduction in hepatic fat
Measured: change from baseline to 6 weeks
Visceral Adipose Tissue Content
Visceral Adipose Tissue Content as measured by magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS)
Measured: change from baseline to 6 weeks
Quality of Life Score
Quality of Life Score as measured by Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD)
Measured: change from baseline to 6 weeks
Dietary Intake
Dietary Intake as measured by caloric intake and nutrient contents, assessed by ASA24
Measured: change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Feb 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Every individual enrolled will follow a special type of diet for 6 weeks, called time-restricted, intermittent fasting.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen E Corey, Massachusetts General Hospital
- Investigators
- Kathleen Corey, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899102
- Sponsor's protocol ID
- 2020P002672
- Status last verified
- Oct 2025
- First submitted
- 19 May 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final Research Data, with all patient identifiers removed, will be available to other researchers through request to the PI. Because information contained in the final research data will include multiple demographic and biological variables that could potentially be used in concert to identify participants, it will be shared only under a Data Sharing Agreement that includes (1) a commitment to using the data only for research purposes and not to identify any individual participant and (2) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Time-Restricted, Intermittent Fasting for Non-Alcoholic Fatty Liver Disease in Non-Obese Adults
- ClinicalTrials.gov ID
- NCT04899102
- Acronym / sponsor ID
- 2020P002672
- Conditions
- Fatty Liver, Intermittent Fasting, Fatty Liver, Nonalcoholic, Non-Alcoholic Fatty Liver Disease, Liver Fat
- Keywords
- Fatty Liver, Intermittent Fasting, Non-obese, Diet, Nutrition, Time-restricted, Liver Fat, Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 May 2021 (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.
NAFLD is a growing threat to public health. Currently, there is a significant need for highly effective treatments for NAFLD. Non-obese NAFLD (BMI<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. The purpose of this study is to identify non-pharmacologic, lifestyle-based methods of NAFLD treatment within non-obese adults.
Detailed description
Nonalcoholic fatty liver disease (NAFLD), which encompasses a spectrum from simple steatosis and steatohepatitis (NASH) to fibrosis and cirrhosis, is the leading cause of liver disease in the United States. There are currently no FDA-approved pharmacologic therapies for NAFLD and NASH, and standard low-calorie diets are often minimally effective, difficult to adhere to and to maintain. Thus, continued investigation of strategies to treat NAFLD and NASH is greatly needed. Non-obese NAFLD (BMI<30kg/m2) is an increasingly recognized condition, sometimes described as "lean NAFLD". It is estimated that 10-20% of American and Europeans without obesity have this condition. There is a pressing need for the study of lifestyle interventions independent of weight loss to treat this important subset of NAFLD patients. This protocol aims to investigate the utility of time restricted, intermittent fasting (TRF) as a potential method. Adults with non-obese NAFLD are at risk of progression to end-stage liver disease and development of cardiometabolic disease. Intermittent Fasting (IF) may be uniquely beneficial in non-obese NAFLD. IF is characterized by periods of dietary restriction leading to metabolic production and use of ketones from adipocytes rather than hepatically-derived glucose.
The goal of this study is to learn if time-restricted, intermittent fasting can help reduce the amount of fat in the liver in adults with non-alcoholic fatty liver disease (NAFLD). Ideally, this study will yield more information about time-restricted, intermittent fasting as a potential lifestyle-based treatment for adults with NAFLD and a body mass index (BMI) between 23-30 kg/m^2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Every individual enrolled will follow a special type of diet for 6 weeks, called time-restricted, intermittent fasting.
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted, Intermittent Fasting Group | Experimental | Behavioral: Time-Restricted, Intermittent FastingSpecial type of diet for 6 weeks, called time-restricted, intermittent fasting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide informed consent
- Age 18 years or older at time of consent
- BMI 23-30kg/m^2 at screening
- Evidence of NAFLD confirmed by historical procedure obtained no more than 6 months prior to the screening visit, defined as:
- Liver fat fraction ≥10% on H-MRS performed during the screening period
Key exclusion criteria (16 listed)
- Heavy alcohol use for at least 3 consecutive months within the past 5 years prior to screening [heavy alcohol consumption is defined as: > 20g daily for women or > 30mg daily for men, assessed by the Lifetime Drinking History assessment at screening (23, 24)].
- Evidence of other known forms of chronic liver disease including:
- Current or prior history of Type II Diabetes requiring insulin or sulfonylureas due to risk of hypoglycemia with fasting.
- Use of any pharmacological treatments for NAFLD/NASH within the 6 months prior to the screening visit, except vitamin E. Patients on a stable dose of vitamin E can be enrolled in the study.
- Unstable body weight [defined as: >10% reduction in body weight in the 6 months prior to the screening visit]
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 |
|---|---|---|
| Time-Restricted, Intermittent FastingA special type of diet for 6 weeks, called time-restricted, intermittent fasting. | Behavioural | Time-Restricted, Intermittent Fasting Group |
Primary outcome
Liver Fat Content
Time frame: change from baseline to 6 weeks
Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy (H-MRS)
4 secondary outcomes
≥30% Relative Liver Fat Reduction Proportion
Time frame: change from baseline to 6 weeks
Visceral Adipose Tissue Content
Time frame: change from baseline to 6 weeks
Quality of Life Score
Time frame: change from baseline to 6 weeks
Dietary Intake
Time frame: change from baseline to 6 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 18 Dec 2025.
- Individual participant dataSharing planned: Yes. Final Research Data, with all patient identifiers removed, will be available to other researchers through request to the PI. Because information contained in the final research data will include multiple demographic and biological variables that could potentially be used in concert to identify participants, it will be shared only under a Data Sharing Agreement that includes (1) a commitment to using the data only for research purposes and not to identify any individual participant and (2) a commitment to destroying or returning the data after analyses are completed.
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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.
Kathleen Corey, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-Restricted, Intermittent Fasting in people with Fatty Liver and Intermittent Fasting, run by Massachusetts General Hospital 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 8 inclusion and 16 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 18 Dec 2025. 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 Kathleen E Corey, MD/MPH (6177265925, kathleen.corey@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Fat Content (time frame: change from baseline to 6 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 18 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.