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Time-Restricted Eating for Metabolic Diseases (TREL Trial)
N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
age 25-75 years
clinical diagnosis of NAFLD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 12 weeks
Awards & highlights
TREL Trial Summary
This trialwill research how restricting food intake to 6-10 hrs/day affects liver health in people with obesity/overweight. Results could provide insight into how meal timing can affect metabolic diseases.
Who is the study for?
This trial is for adults aged 25-75 with a BMI of 25-45 kg/m2 who eat over a period of more than 14 hours daily and have been clinically diagnosed with non-alcoholic fatty liver disease (NAFLD). It's not suitable for those with certain dietary habits, gastrointestinal surgeries, sleep or eating disorders, heavy metal presence in the body, recent cancer history, pregnancy, alcohol abuse, unstable weight or diabetes.Check my eligibility
What is being tested?
The study tests if limiting food intake to a 9-hour window each day can improve liver health in people with obesity-related NAFLD. Over 12 weeks, participants will be randomly assigned to follow this time-restricted eating pattern without changing their calorie intake. Liver fat and metabolism will be measured using MRI scans and special water tracing techniques.See study design
What are the potential side effects?
Since this intervention involves dietary timing rather than medication or surgery, side effects may include hunger during fasting periods, potential changes in energy levels or mood swings due to altered meal times. No direct medical side effects are expected from the time-restricted eating itself.
TREL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 75 years old.
Select...
I have been diagnosed with fatty liver disease.
TREL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ about 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Intrahepatic triglyceride (IHTG) content
Change in de novo lipogenesis (DNL)
Change in glucose, free fatty acid and triglyceride levels in response to a meal
TREL Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: TRE isocaloricExperimental Treatment1 Intervention
Subjects will consume all meals/snacks during a ~9-h daily eating period (~15-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance.
Group II: TRE ad libitumExperimental Treatment1 Intervention
Subjects will consume all meals/snacks during a ~9-h daily eating period (~15-h fasting) without any other dietary advice.
Group III: ControlActive Control1 Intervention
Subjects will consume all meals/snacks during a ~15-h daily eating period (~9-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted eating
2021
N/A
~130
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Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,973 Total Patients Enrolled
29 Trials studying Obesity
33,551 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of drinking too much alcohol regularly.I have not had surgery that affects how my body digests food and absorbs nutrients, I can follow study instructions, and I am an adult.I have diabetes or liver disease due to alcohol use.Your body mass index (BMI) falls between 25 and 45 kg/m2.I am not on medications that could interfere with the study or increase risk.You have had or currently have an eating disorder.Individuals who are currently in prison.I am between 25 and 75 years old.You have problems with thinking or memory.You usually eat for 14 or more hours every day.I was diagnosed with cancer within the last 5 years.You cannot stay completely still in the MRI scanner for an hour or have tattoos or tattooed eyeliner.I have a sleep disorder.You have a consistent habit of waking up before 4:00 am and going to bed before 10:30 pm.Your weight has been changing a lot in the past two months, by more than 5%.I am either a man or a woman.You smoke cigarettes or use illegal drugs.I have been diagnosed with fatty liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: TRE isocaloric
- Group 3: TRE ad libitum
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.
Obesity Patient Testimony for trial: Trial Name: NCT04997486 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the prerequisites for enrollment in this exploration?
"Eligibility criteria for this trial necessitates that participants have obesity and are aged between 25 and 75. 18 applicants in total will be taken into the study."
Answered by AI
Is geriatric participation being sought in this research endeavor?
"The prerequisites for enrolment in this study are that patients need to be between 25 and 75 years of age."
Answered by AI
What is the uppermost participant threshold for this clinical experiment?
"Affirmative. The details on clinicaltrials.gov verify that this medical test is currently open for participants, which was first posted in July 2021 and the most recent update being September 2022. This trial seeks 18 individuals from a single location to take part."
Answered by AI
Are there currently opportunities for individuals to be part of this experiment?
"Clinicaltrials.gov displays that this research endeavour is still looking for volunteers; the study was initially posted on July 20th 2021 and recently updated on September 21st 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California, Davis
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 believe that this will help alng.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long are visits including any waiting time?
PatientReceived no prior treatments
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