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Time-Restricted Eating for Prediabetes

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
Be older than 18 years old
Must not have
Menopause
Cancer in last 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months (pre-post intervention)
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of time-restricted eating, or TRE, on key metabolic outcomes in people with obesity and prediabetes. TRE involves restricting food intake to 6-12 hours per day, with no energy intake the rest of the day. The trial will last 12 weeks, and will help researchers understand the implications of TRE on cardiometabolic health.

Who is the study for?
This trial is for adults with obesity (BMI of 30-39.9) and prediabetes, who usually eat over a 15-hour period daily, and have stable weight without major chronic diseases or recent cancer. It's not for shift workers, frequent travelers across time zones, those doing structured exercise over 150 minutes weekly, with sleep disorders or unstable diets.
What is being tested?
The study tests if eating within a 9-hour window can improve heart health and blood sugar control in people with obesity and prediabetes. Participants will follow this diet for 12 weeks to see changes in insulin sensitivity and body rhythms without losing weight.
What are the potential side effects?
While the trial doesn't involve medication that could cause side effects, changing eating patterns may lead to hunger outside of the eating window, potential digestive discomfort as the body adjusts to new meal times, or changes in energy levels.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have gone through menopause.
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I was diagnosed with cancer within the last 5 years.
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I am under the age of 18.
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I have had surgery on my digestive system or for weight loss.
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I am able to understand and follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months (pre-post intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months (pre-post intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
24 h glycemic control
Adipose tissue gene expression
Insulin sensitivity
Secondary study objectives
Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: TRE groupExperimental Treatment1 Intervention
Time-restricted eating group
Group II: Control groupExperimental Treatment1 Intervention
Time-unrestricted eating group

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
936 Previous Clinical Trials
4,719,674 Total Patients Enrolled
30 Trials studying Obesity
33,619 Patients Enrolled for Obesity

Media Library

Time-Restricted Eating Clinical Trial Eligibility Overview. Trial Name: NCT04484987 — N/A
Obesity Research Study Groups: TRE group, Control group
Obesity Clinical Trial 2023: Time-Restricted Eating Highlights & Side Effects. Trial Name: NCT04484987 — N/A
Time-Restricted Eating 2023 Treatment Timeline for Medical Study. Trial Name: NCT04484987 — N/A
~11 spots leftby Oct 2025
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