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Intermittent Fasting for Non-alcoholic Fatty Liver Disease
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 6 weeks
Awards & highlights
Study Summary
This trial will test the benefits of Intermittent Fasting for treating Non-Alcoholic Fatty Liver Disease in people who are not obese.
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.Check my eligibility
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.See study design
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 belowSelect...
I have a liver condition with some fat buildup.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Liver Fat Content
Secondary outcome measures
Dietary Intake
Quality of Life Score
Visceral Adipose Tissue Content
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,420 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced with an eGFR below 60.I have had a liver transplant or am on the liver transplant list.I have a chronic liver disease.I have a liver condition with some fat buildup.I haven't taken any drugs for fatty liver disease in the last 6 months, except vitamin E.I have advanced liver disease or cirrhosis.My weight has not dropped more than 10% in the last 6 months.I have had, or plan to have, weight loss surgery, am taking weight loss medications, or am actively participating in a weight loss program.I have a liver condition such as hepatitis or fatty liver disease.I have Type II Diabetes and take insulin or sulfonylureas.Your body mass index (BMI) falls between 23-30 kg/m^2 at the time of screening.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Time-Restricted, Intermittent Fasting Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04899102 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available to participate in this research study?
"Data on clinicaltrials.gov indicates that this research is currently seeking participants, having first been posted back in February 1st 2022 and recently modified on March 9th this year."
Answered by AI
How many individuals have been selected to partake in this experiment?
"Affirmative. The information on clinicaltrials.gov indicates that this medical trial is actively recruiting participants; it was initially posted on February 1st 2022 and last modified on March 9th 2022. Specifically, 25 patients have to be recruited from one site for the study's completion."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
65+
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have NAFLD and would like to help with a treatment for this condition.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
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