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Behavioral Intervention

Time-Restricted Eating for Obesity and Insulin Resistance (MEDITRE Trial)

N/A
Recruiting
Led By Candida Rebello
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Weight change > 3 kg in the preceding three months
Diagnosis of type 1 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial aims to test if eating within a specific time window and consuming a low-calorie dense diet can help older adults with obesity and insulin resistance to reduce insulin resistance and body weight. Participants will be

Who is the study for?
This trial is for older adults who are overweight and have insulin resistance. Participants should be willing to follow a time-restricted eating plan, which includes fasting for 14 hours and having a 10-hour window for eating.
What is being tested?
The study is testing the effects of two diets during time-restricted eating: one group will eat foods with fewer calories per gram (low-energy dense diet), while the other will eat their usual diet. The goal is to see if this affects body weight and insulin resistance.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include hunger or discomfort due to the new eating schedule and potential changes in digestion or energy levels.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My weight has changed by more than 3 kg in the last 3 months.
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I have been diagnosed with type 1 diabetes.
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I have had cancer within the last five years.
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I have kidney problems that affect my health.
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I am currently taking steroids, olanzapine, or clozapine.
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I am taking prescription medication for obesity.
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I am currently taking diabetes medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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
Body weight
Brain Insulin Resistance
Ketones
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low energy dense dietExperimental Treatment1 Intervention
Subjects will be required to follow time-restricted eating and receive a diet low in energy density
Group II: Usual dietActive Control1 Intervention
Subjects will be required to follow time-restricted eating and receive the usual diet.

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
307 Previous Clinical Trials
181,121 Total Patients Enrolled
65 Trials studying Obesity
117,529 Patients Enrolled for Obesity
Candida RebelloPrincipal InvestigatorPennington Biomedical Research Center
1 Previous Clinical Trials
18 Total Patients Enrolled
~27 spots leftby Dec 2025
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