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Behavioral Intervention

Diet and Meal Timing for Non-Alcoholic Fatty Liver Disease

Q: To what extent is eligibility for this experiment open to the public?

To become a participant in this research, an individual must have been diagnosed with liver disease and should not be older than 65 or younger than 18. Approximately 40 patients are required for the study to commence.

Q: How many participants have registered for this trial to date?

Indeed, this study is currently recruiting. The trial was posted on May 9th 2022 and recently updated on the 23rd. 40 participants are being sought from 1 research facility to participate in this experiment.

Q: Is senior citizen participation encouraged in this clinical trial?

Patients 18 to 65 years old are eligible for the trial at hand; however, there exist 33 trials that accept those younger and 319 specifically tailored towards senior citizens.

Q: Are there any available openings for patients to join this clinical research?

Clinicaltrials.gov reports that this medical trial, initially published on May 9th 2022, is still in need of participants. The listing was most recently amended on the 23rd of May 2022.

N/A

Recruiting

Led By Sonal Kumar, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 and < 65 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will study the effect of time-restricted eating on liver fat in people with prediabetes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include hunger during fasting periods, possible nutritional deficiencies if the diet isn't well-balanced, fatigue due to calorie restriction, and stress from lifestyle changes.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks

Secondary outcome measures

Mean Change from Baseline in BMI at 12 weeks

Mean Change from Baseline in Body Composition Measurements at 12 weeks

Mean Change from Baseline in Liver Stiffness on Fibroscan® at 12 weeks

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: TRE plus SOCExperimental Treatment1 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 TREExperimental Treatment1 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: SOCActive Control1 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,255 Total Patients Enrolled

2 Trials studying Non-alcoholic Fatty Liver Disease

61 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Sonal Kumar, MDPrincipal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

48 Total Patients Enrolled

1 Trials studying Non-alcoholic Fatty Liver Disease

48 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

TRE plus SOC (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05332613 — N/A

Non-alcoholic Fatty Liver Disease Research Study Groups: SOC, Crossover to TRE, TRE plus SOC

Non-alcoholic Fatty Liver Disease Clinical Trial 2023: TRE plus SOC Highlights & Side Effects. Trial Name: NCT05332613 — N/A

TRE plus SOC (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05332613 — N/A

Frequently Asked Questions

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

To what extent is eligibility for this experiment open to the public?

"To become a participant in this research, an individual must have been diagnosed with liver disease and should not be older than 65 or younger than 18. Approximately 40 patients are required for the study to commence."

Answered by AI

How many participants have registered for this trial to date?

"Indeed, this study is currently recruiting. The trial was posted on May 9th 2022 and recently updated on the 23rd. 40 participants are being sought from 1 research facility to participate in this experiment."

Answered by AI

Is senior citizen participation encouraged in this clinical trial?

"Patients 18 to 65 years old are eligible for the trial at hand; however, there exist 33 trials that accept those younger and 319 specifically tailored towards senior citizens."

Answered by AI

Are there any available openings for patients to join this clinical research?

"Clinicaltrials.gov reports that this medical trial, initially published on May 9th 2022, is still in need of participants. The listing was most recently amended on the 23rd of May 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study

2022. "Diet and Meal Timing in Patients With Non-Alcoholic Fatty Liver Disease: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05332613.

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