Diet and Meal Timing for Non-Alcoholic Fatty Liver Disease

Overseen By Lindsay Rogers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Alcohol use, Cirrhosis, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how time-restricted eating (eating only during an 8-hour window each day) affects liver fat in individuals following a Mediterranean diet and regular exercise plan. The researchers aim to determine if this method can reduce liver fat in those with non-alcoholic fatty liver disease (NAFLD). Participants who do not achieve sufficient weight loss can switch to the time-restricted eating plan for further observation. Ideal candidates have a body mass index (BMI) over 25 and liver fat content of at least 10%, and do not already fast regularly. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve liver health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on a medication that requires you to eat at specific times, you may need to discuss this with the study team due to the time-restricted eating schedule.

What prior data suggests that this time-restricted eating regimen is safe?

Research has shown that time-restricted eating (TRE) is generally safe. Studies have found that this eating pattern can help reduce body weight and liver fat without major side effects. For instance, one study reported a 25.8% decrease in liver fat for those following TRE. Another study found that TRE can also lower body fat and cholesterol levels. These results suggest that TRE is well-tolerated and might be a safe way to reduce liver fat. It is important to consult a healthcare professional before changing your diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the time-restricted eating (TRE) approach for Non-Alcoholic Fatty Liver Disease because it introduces a novel way to manage the condition by focusing on when you eat, not just what you eat. Unlike traditional methods that emphasize only diet and exercise, TRE involves eating within a set eight-hour window each day, which may help improve metabolism and liver health. This method is paired with standard lifestyle changes, like a low-calorie diet and moderate exercise, but adds a unique twist by potentially enhancing the body's natural rhythms and offering a fresh angle on weight management.

What evidence suggests that this trial's treatments could be effective for non-alcoholic fatty liver disease?

Research has shown that time-restricted eating (TRE), which involves eating only during an 8-hour period each day, may improve liver health in people with non-alcoholic fatty liver disease (NAFLD). In this trial, participants in the TRE plus SOC arm will follow this regimen. Studies have found that TRE can lower liver fat, reduce liver stiffness, and aid in weight loss. These changes enhance overall liver function and health. Another study found that TRE, when combined with a low-calorie Mediterranean diet and regular exercise, can be as effective for weight loss as other calorie-reducing methods. This suggests that TRE could be a promising way to manage NAFLD effectively. Participants in the SOC arm will receive standard lifestyle recommendations, including a low-calorie diet and moderate-intensity exercise. ^{1 2 4 6 7}

Who Is on the Research Team?

Sonal Kumar, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This study is for adults aged 18-64 with a BMI over 25 and at least 10% liver fat content, who can follow the protocol. It's not for those with other liver diseases, significant alcohol use, recent weight loss of more than 5%, or conditions preventing MRI tests or fasting.

Inclusion Criteria

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

Exclusion Criteria

Competing etiologies for hepatic steatosis

I have lost 5% or more of my weight in the last 3 months.

I am mentally capable of understanding and following the study's requirements.

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 eating regimen for 12 weeks, with lifestyle recommendations including a low-calorie diet and moderate-intensity exercise

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat Fibroscan, InBody 770 body composition scan, and MRI-PDFF

4 weeks

Crossover to TRE (optional)

Participants who have not lost sufficient weight may opt to crossover to the TRE arm for another 12-week cycle

12 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SOC
• TRE plus SOC

Trial Overview

The trial examines time-restricted eating (eating within an 8-hour window) combined with standard care (low-calorie Mediterranean diet and exercise) versus standard care alone on liver fat reduction in non-alcoholic fatty liver disease patients.

How Is the Trial Designed?

Group I: TRE plus SOC Experimental Treatment 1 Intervention

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.

Group II: Crossover to TRE Experimental Treatment 1 Intervention

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.

Group III: SOC Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

In a 12-month clinical trial involving 88 participants with obesity and nonalcoholic fatty liver disease (NAFLD), both time-restricted eating (TRE) and daily calorie restriction (DCR) resulted in similar reductions in intrahepatic triglyceride (IHTG) content, indicating that TRE does not offer additional benefits over DCR for this condition.

Both TRE and DCR led to significant reductions in liver stiffness, body weight, and metabolic risk factors, emphasizing that caloric intake restriction is crucial for managing NAFLD, regardless of the eating pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial. Wei, X., Lin, B., Huang, Y., et al.[2023]

In a study of 3813 participants, those who practiced time-restricted eating (TRE) with a daily eating window of 8 hours or less had a 30% lower odds of developing non-alcoholic fatty liver disease (NAFLD) compared to those with a longer eating window.

The association between TRE and reduced NAFLD risk was found to be independent of physical activity and diet quality, and was particularly strong in individuals with lower energy intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between time-restricted eating and non-alcoholic fatty liver disease in a nationwide cross-sectional study. Zeng, X., Xie, S., Jiang, F., et al.[2023]

Lifestyle changes, particularly optimizing nutrition and increasing physical activity, are crucial for improving or resolving non-alcoholic fatty liver disease (NAFLD).

Among various dietary interventions studied in 317 adults with NAFLD, the Mediterranean Diet showed the most significant reductions in liver fat and weight loss, indicating its potential effectiveness, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Dietary Approaches for the Treatment of Non-Alcoholic Fatty Liver Disease: A Systematic Review. Saeed, N., Nadeau, B., Shannon, C., et al.[2020]

Intermittent fasting has been shown to significantly reduce body weight, body mass index (BMI), and improve liver enzymes (ALT and AST) in adults with non-alcoholic fatty liver disease (NAFLD), based on a meta-analysis of six studies involving 417 patients.

While intermittent fasting appears effective for weight management and liver health, further research is needed to assess its long-term safety and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Intermittent Fasting on Non-Alcoholic Fatty Liver Disease: Systematic Review and Meta-Analysis. Yin, C., Li, Z., Xiang, Y., et al.[2021]

The timing of energy intake throughout the day is crucial for liver health, with irregular meal patterns, skipping breakfast, and late-night eating linked to a higher risk of non-alcoholic fatty liver disease (NAFLD).

Intermittent fasting and time-restricted eating may improve metabolic health and benefit patients with NAFLD by restoring natural circadian rhythms, as supported by both observational studies and pilot human trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of energy intake and the therapeutic potential of intermittent fasting and time-restricted eating in NAFLD. Marjot, T., Tomlinson, JW., Hodson, L., et al.[2023]

Intermittent fasting has been shown to promote weight loss, reduce inflammation, and improve gut health, making it a promising dietary approach for managing obesity and metabolic syndrome.

While there is some evidence suggesting potential benefits of intermittent fasting for nonalcoholic fatty liver disease, more clinical studies are needed to confirm its safety and efficacy specifically for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Intermittent Fasting in the Management of Nonalcoholic Fatty Liver Disease: A Narrative Review. Lavallee, CM., Bruno, A., Ma, C., et al.[2022]

In a study of 32 participants with non-alcoholic fatty liver disease (NAFLD), time-restricted fasting (TRF) for 16 hours daily led to significant reductions in liver fat (steatosis), weight, waist circumference, and BMI compared to standard care over 12 weeks.

TRF proved to be more effective than standard dietary advice, suggesting it could be a primary intervention for weight loss and management of NAFLD without requiring calorie restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Fasting Improves Liver Steatosis in Non-Alcoholic Fatty Liver Disease-A Single Blinded Crossover Trial. Feehan, J., Mack, A., Tuck, C., et al.[2023]

A 10-week diet plus exercise program significantly improved liver health and overall fitness in patients with nonalcoholic fatty liver disease (NAFLD), showing better results than exercise alone.

While both diet-plus-exercise and exercise-only programs improved health markers like body weight and insulin sensitivity, only the diet-plus-exercise group showed significant improvements in liver biochemistry, highlighting its greater efficacy in treating NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic lifestyle program on ultrasound-diagnosed nonalcoholic fatty liver disease. Chen, SM., Liu, CY., Li, SR., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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