CLINICAL TRIAL

Time-Restricted, Intermittent Fasting for Nonalcoholic Steatohepatitis

Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a specific diet may help reduce the symptoms of non-obese fatty liver disease.

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About the trial for Nonalcoholic Steatohepatitis

Eligible Conditions
Liver Diseases · Nonalcoholic Fatty Liver · Fatty Liver · Fasting, Intermittent · Non-alcoholic Fatty Liver Disease · Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD · Liver Fat

Treatment Groups

This trial involves 2 different treatments. Time-Restricted, Intermittent Fasting is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Time-Restricted, Intermittent Fasting
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18 years or older at time of consent
BMI 23-30kg/m^2 at screening
Willing and able to provide informed consent
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: change from baseline to 6 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 6 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: change from baseline to 6 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Time-Restricted, Intermittent Fasting will improve 1 primary outcome and 4 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of change from baseline to 6 weeks.

Dietary Intake
CHANGE FROM BASELINE TO 6 WEEKS
Dietary Intake as measured by caloric intake and nutrient contents, assessed by ASA24
CHANGE FROM BASELINE TO 6 WEEKS
Visceral Adipose Tissue Content
CHANGE FROM BASELINE TO 6 WEEKS
Visceral Adipose Tissue Content as measured by magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS)
CHANGE FROM BASELINE TO 6 WEEKS
≥30% Relative Liver Fat Reduction Proportion
CHANGE FROM BASELINE TO 6 WEEKS
Proportion of subjects with a ≥30% relative reduction in hepatic fat
CHANGE FROM BASELINE TO 6 WEEKS
Liver Fat Content
CHANGE FROM BASELINE TO 6 WEEKS
Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy (H-MRS)
CHANGE FROM BASELINE TO 6 WEEKS
Quality of Life Score
CHANGE FROM BASELINE TO 6 WEEKS
Quality of Life Score as measured by Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD)
CHANGE FROM BASELINE TO 6 WEEKS

Who is running the study

Principal Investigator
K. E. C.
Prof. Kathleen E Corey, Director, Fatty Liver Clinic Assistant Professor, Harvard Medical School
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can nonalcoholic steatohepatitis be cured?

Results from a recent paper suggests that a combination of lipid-lowering agents and ursodeoxycholic acid has the potential to induce complete remission and ameliorate hepatic fibrosis in patients with nonalcoholic steatohepatitis.

Anonymous Patient Answer

What causes nonalcoholic steatohepatitis?

Based on current research, obesity and metabolic syndrome can be a predisposing factor for development of nonalcoholic steatohepatitis. Obesity alters the body's normal metabolic homeostasis, which leads to a proinflammatory state. This is evidenced by elevated levels of inflammatory markers and greater levels of proinflammatory cytokines. Metabolic syndrome appears to worsen or cause NASH, whereas NASH worsens the condition by causing systemic damage. This leads to more fat in the liver, inducing hepatic fibrosis and cirrhosis. Over time, the liver can become damaged and eventually has to be transplanted. Fibrosis may persist for several years following transplantation.

Anonymous Patient Answer

What are common treatments for nonalcoholic steatohepatitis?

Dietary therapy as the cornerstone of management of NASH is not fully understood today. While most patients have a favorable clinical course when being treated with diet, the extent to which non-digestible carbohydrates (carbohydrates or fructogen-rich) can decrease the progression of liver disease and fibrosis is currently unknown.

Anonymous Patient Answer

What are the signs of nonalcoholic steatohepatitis?

No single criteria allows a positive identification of NASH. Nevertheless, there are four signs that can be a help in diagnosis. The signs are: 1) abnormal serum aminotransferase levels and 2) abnormal imaging (ultrasound, MRI, CT or MR cholangiogram) in a non-pancreas context, 3) high levels of alanine aminotransferase and 4) high levels of ferritin.

Anonymous Patient Answer

What is nonalcoholic steatohepatitis?

Nonalcoholic steatohepatitis can result in a variety of health complications, including weight loss, enlargement of the liver, inflammation, and cirrhosis. The lack of an identifiable hereditary component is an important consideration in management.

Anonymous Patient Answer

How many people get nonalcoholic steatohepatitis a year in the United States?

Rates of NASH in the United States appeared to be declining; however, NASH rates remain high compared with U.S. data of other populations. NASH affects women at higher rates than anticipated and is a cause of cirrhosis.

Anonymous Patient Answer

Has time-restricted, intermittent fasting proven to be more effective than a placebo?

Intermittent fasting for 5 days is more effective than a placebo in treating obesity and NAFLD in both a 10-kg weight deficit and a 20-kg weight deficit model. This effect is most likely attributable to a reduction in both total fat mass and circulating insulin. It is hoped that intermittent fasting will improve the treatment of obesity, and potentially, NAFLD and related metabolic diseases.

Anonymous Patient Answer

How serious can nonalcoholic steatohepatitis be?

Nonalcoholic steatohepatitis is a chronic inflammatory problem characterized by hepatic dysfunction related to oxidative stress. Liver injury is typically mild to moderate but often progressive. Some patients may undergo a hepatic event such as hepatic encephalopathy, hepatorenal syndrome, or acute-on-chronic liver failure requiring liver transplantation. Hepatosplenic syndrome is rare. Lymphoproliferative disorder, hepatitis B, and hepatitis C, the most common chronic viral hepatitis, are the most severe complications of nonalcoholic steatohepatitis and, in those who are infected with hepatitis B and C, hepatic carcinoma may be an unavoidable consequence.

Anonymous Patient Answer

How does time-restricted, intermittent fasting work?

An 16-hour intermittent fast reduces hepatic stearoyl-CoA biosynthesis and enhances insulin sensitivity in nondiabetic normal-weight individuals without altering serum lipid profile, plasma glucose, or hepatic glycogen.

Anonymous Patient Answer

What does time-restricted, intermittent fasting usually treat?

The time-restricted, intermittent fast does not treat NASH, as previously proposed, although a diet rich in green foods reduces steatosis. It may be hypothesized that this treatment should be used only as a complementary, non-contradictory, or complementary-alternative-medication to the conventional treatment of NASH (or in the absence of a contraindication).

Anonymous Patient Answer

What is time-restricted, intermittent fasting?

Given the lack of data about time-restricted intermittent fasting on metabolic pathways, metabolic functions and body composition, long-duration intermittent fasts are currently not recognized as a legitimate form of nutritional interventions. Further, data on effects of longer duration intermittent fasts are scarce. Current recommendations are that people should not restrict calories and should only skip meals every 2 h or less if possible. Nevertheless, time-restricted intermittent fasting may be used as a complementary way of nutrition, with or without exercise, to improve some features of dieting in people with chronic disease.

Anonymous Patient Answer

Have there been any new discoveries for treating nonalcoholic steatohepatitis?

Few randomized trial have been published with a primary endpoint related to treatment of NASH. The only positive findings that we have seen are from the combination and weight loss. There is an urgent need for more clinical trials evaluating new disease modifying treatments for NASH.

Anonymous Patient Answer
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