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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

Must not have

diabetes mellitus or alcoholic liver disease

cancer in last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up about 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 25 and 75 years old.

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I have been diagnosed with fatty liver disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes or liver disease due to alcohol use.

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I was diagnosed with cancer within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~about 12 weeks

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met