What side effects are associated with this type of intervention?

Intermittent fasting, including alternate-day fasting, is generally well-tolerated but can lead to side effects such as hunger, irritability, and reduced concentration during fasting periods. Other common treatments for Fatty Liver Disease, such as restricted diets and exercise, may cause initial fatigue, muscle soreness, and gastrointestinal discomfort. Pharmacologic treatments like orlistat can cause gastrointestinal issues, including oily stools and flatulence. It is important to monitor these side effects and consult with a healthcare provider to ensure the chosen treatment is safe and effective.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). However, some medications used for other conditions have shown benefits in treating these liver diseases. For instance, pioglitazone, a drug for type 2 diabetes, has been studied for its potential to reduce liver fat and improve liver histology in NASH patients. Similarly, metformin, another diabetes medication, has been associated with decreased risk of hepatocellular carcinoma in patients with chronic liver disease. Lifestyle interventions, such as diet and exercise, remain the cornerstone of managing NAFLD and NASH, with intermittent fasting being a promising non-pharmacologic approach to improve metabolic health and reduce liver fat.

What other types of research exist?

Promising novel alternatives to intermittent fasting for treating fatty liver disease in 2024 include: 1) Low-carbohydrate and high-protein diets, which can reduce intrahepatocellular lipids and improve metabolic health. 2) Flaxseed supplementation (30g/day), which has shown significant reductions in liver enzymes, insulin resistance, and hepatic fibrosis and steatosis. 3) Reversing sedentary lifestyles, which can significantly improve liver enzymes, lipid profiles, fasting blood glucose, insulin levels, and body composition.

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Intermittent Fasting for Non-alcoholic Fatty Liver Disease

Q: What is the mechanism of action of this treatment?

Common treatments for Fatty Liver Disease (FLD) include lifestyle interventions like intermittent fasting (IF) and dietary modifications, as well as pharmacologic treatments such as ursodeoxycholic acid and obeticholic acid. IF involves periods of eating and fasting, which can improve insulin sensitivity and reduce liver fat by promoting metabolic changes. Dietary modifications, including caloric restriction and the consumption of whole grains and healthy fats, help manage weight and improve glycemic control. Ursodeoxycholic acid and obeticholic acid work by enhancing bile acid metabolism and reducing cholesterol absorption, which can lower liver fat and improve liver function. These treatments are crucial for FLD patients as they target the underlying metabolic dysfunctions, potentially reversing liver damage and preventing progression to more severe liver diseases.

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Grade >=1 steatosis on clinical liver biopsy; OR

Be older than 18 years old

Must not have

Chronic Kidney Disease (CKD) with eGFR < 60

History of liver transplant, or current placement on a liver transplant list

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Intermittent fasting may lead to hunger, fatigue, headaches, irritability, difficulty concentrating and potential nutrient deficiencies if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a liver condition with some fat buildup.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced with an eGFR below 60.

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I have had a liver transplant or am on the liver transplant list.

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I have advanced liver disease or cirrhosis.

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My weight has not dropped more than 10% in the last 6 months.

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I have a liver condition such as hepatitis or fatty liver disease.

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I have Type II Diabetes and take insulin or sulfonylureas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Liver Fat Content

Secondary study objectives

Dietary Intake

Quality of Life Score

Visceral Adipose Tissue Content

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Fatty Liver Disease (FLD) include lifestyle interventions like intermittent fasting (IF) and dietary modifications, as well as pharmacologic treatments such as ursodeoxycholic acid and obeticholic acid. IF involves periods of eating and fasting, which can improve insulin sensitivity and reduce liver fat by promoting metabolic changes. Dietary modifications, including caloric restriction and the consumption of whole grains and healthy fats, help manage weight and improve glycemic control. Ursodeoxycholic acid and obeticholic acid work by enhancing bile acid metabolism and reducing cholesterol absorption, which can lower liver fat and improve liver function. These treatments are crucial for FLD patients as they target the underlying metabolic dysfunctions, potentially reversing liver damage and preventing progression to more severe liver diseases.

Therapeutic effects of restricted diet and exercise in obese patients with fatty liver.