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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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months (pre-post intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months (pre-post intervention)
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have gone through menopause.Your blood sugar levels are moderately high when fasting or after a glucose test.I was diagnosed with cancer within the last 5 years.I am under the age of 18.I have a sleep disorder.You use tobacco or illegal drugs.You should not eat any food after 6:00 pm once a week.You typically eat for more than 15 hours each day.I am not on medications that could interfere with the study.You work night shifts or have recently traveled across different time zones.I have type 2 diabetes or another major chronic illness.You have had a lot of exposure to radiation from medical procedures in the past year.You regularly fast for more than 12 hours a day, or you follow a vegan diet.You usually wake up before 4:00 AM and go to bed before 10:30 PM.I have had surgery on my digestive system or for weight loss.Your body mass index is between 30 and 39.9, which means you are considered obese.You need to exercise for at least 150 minutes every week.Your weight has changed by more than 5% in the last 2 months.I am able to understand and follow the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: TRE group
- Group 2: Control 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.
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