25 Participants Needed

Intermittent Fasting for Non-alcoholic Fatty Liver Disease

KE
JL
HS
Overseen ByHayley Schultz, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying if time-restricted, intermittent fasting can help reduce liver fat in adults who are not obese. The idea is that fasting will make the body burn fat for energy instead of sugar, which might help decrease liver fat. Intermittent fasting has shown favorable effects on body weight and relevant indicators of liver health in several reports.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used any pharmacological treatments for NAFLD/NASH in the past 6 months, except for vitamin E. If you're on a stable dose of vitamin E, you can still join the study.

Is intermittent fasting safe for humans?

Intermittent fasting, including alternate-day fasting and time-restricted eating, has been studied in humans and is generally considered safe, showing benefits like weight management and improved liver enzymes. However, long-term safety data is still needed, so it's important to consult with a healthcare provider before starting any fasting regimen.12345

How is intermittent fasting different from other treatments for non-alcoholic fatty liver disease?

Intermittent fasting, such as alternate-day fasting or time-restricted eating, is unique because it focuses on meal timing rather than specific foods or medications, offering a non-drug approach to reduce liver fat and improve metabolic health. Unlike standard treatments that may involve medication or continuous calorie restriction, intermittent fasting allows for periods of normal eating, which can be easier to maintain and has shown promising results in reducing liver fat and improving lipid profiles.12456

What data supports the effectiveness of the treatment Intermittent Fasting for Non-alcoholic Fatty Liver Disease?

Research shows that intermittent fasting, including alternate-day fasting, can help reduce liver fat and improve liver health in people with non-alcoholic fatty liver disease (NAFLD). Studies found that combining alternate-day fasting with exercise significantly reduced liver fat compared to exercise alone or no intervention.12457

Are You a Good Fit for This Trial?

Adults with non-obese NAFLD (BMI between 23-30), confirmed by a recent liver assessment, who are not heavy drinkers, without other chronic liver diseases or severe illnesses. Participants must not be on weight loss treatments or have unstable body weight and should not be pregnant or trying to conceive.

Inclusion Criteria

Evidence of NAFLD confirmed by historical procedure obtained no more than 6 months prior to the screening visit, defined as:
Hepatitis C antibody and Hepatitis B surface antigen negative at screening
Willing and able to provide informed consent
See 3 more

Exclusion Criteria

Known positivity for human immunodeficiency virus infection
My kidney function is reduced with an eGFR below 60.
I have had a liver transplant or am on the liver transplant list.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a time-restricted, intermittent fasting diet for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Intermittent Fasting
Trial Overview The trial is exploring the effects of Intermittent Fasting as a lifestyle treatment for adults with Non-alcoholic Fatty Liver Disease (NAFLD) who aren't obese. It aims to find non-drug methods to manage this condition.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Time-Restricted, Intermittent Fasting GroupExperimental Treatment1 Intervention
Special type of diet for 6 weeks, called time-restricted, intermittent fasting.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Published Research Related to This Trial

A study involving 98 NAFLD patients showed that 16 hours of daily fasting during Ramadan significantly improved liver enzymes (ALT and AST) and lipid profiles, with some patients achieving normalization of ALT levels after one month of fasting.
Intermittent fasting also led to reductions in body mass index (BMI) and improvements in glycemic indices, indicating its potential as an effective lifestyle modification for managing NAFLD, especially in early phases and among prediabetic individuals.
Impact of intermittent fasting on laboratory, radiological, and anthropometric parameters in NAFLD patients.Badran, H., Elsabaawy, M., Sakr, A., et al.[2022]
In a study of 80 adults with obesity and non-alcoholic fatty liver disease (NAFLD), combining alternate day fasting (ADF) with exercise significantly reduced intrahepatic triglyceride (IHTG) content by 5.48% over 3 months, compared to minimal changes in the exercise and control groups.
While the combination of ADF and exercise improved liver health markers and body composition, it did not show significantly greater benefits compared to ADF alone, suggesting that fasting alone may be sufficient for reducing liver fat in NAFLD patients.
Effect of alternate day fasting combined with aerobic exercise on non-alcoholic fatty liver disease: A randomized controlled trial.Ezpeleta, M., Gabel, K., Cienfuegos, S., et al.[2023]
In a study of 271 patients with non-alcoholic fatty liver disease (NAFLD), alternate-day fasting (ADF) led to significant weight loss and fat mass reduction within just 4 weeks, with continued improvements over 12 weeks.
ADF also resulted in a notable decrease in total cholesterol and triglycerides, indicating its potential effectiveness in improving lipid profiles in NAFLD patients, although further research is needed to confirm its long-term cardiovascular benefits.
Effects of alternate-day fasting on body weight and dyslipidaemia in patients with non-alcoholic fatty liver disease: a randomised controlled trial.Cai, H., Qin, YL., Shi, ZY., et al.[2020]

Citations

Impact of intermittent fasting on laboratory, radiological, and anthropometric parameters in NAFLD patients. [2022]
Effect of alternate day fasting combined with aerobic exercise on non-alcoholic fatty liver disease: A randomized controlled trial. [2023]
Effects of alternate-day fasting on body weight and dyslipidaemia in patients with non-alcoholic fatty liver disease: a randomised controlled trial. [2020]
The effects of fasting diets on nonalcoholic fatty liver disease. [2023]
Alternate-day fasting alleviates high fat diet induced non-alcoholic fatty liver disease through controlling PPARα/Fgf21 signaling. [2022]
Effect of Intermittent Fasting on Non-Alcoholic Fatty Liver Disease: Systematic Review and Meta-Analysis. [2021]
Time-Restricted Fasting Improves Liver Steatosis in Non-Alcoholic Fatty Liver Disease-A Single Blinded Crossover Trial. [2023]
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