MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
NCT ID: NCT03504683
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2020-08-17
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Early TRE
Early TRE
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
Mid-day TRE
Mid-day TRE
Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
Control Schedule
Control Schedule
Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
Interventions
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Early TRE
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
Mid-day TRE
Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
Control Schedule
Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c \>= 5.1%
* Fasting insulin less than 100.0 mU/l and, if HbA1c \<5.7%, must also have fasting insulin \>= 8.0 mU/l
* BMI between 30-60 kg/m\^2
* Wake up at a regular time between 5-8 am
Exclusion Criteria
* On weight loss medication
* Change in the dosage of a chronic medication within the past 2 months
* Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
* Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
* Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
* Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
* Pregnant or breastfeeding
* Diagnosed psychiatric conditions
* Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night
* Major change in health or medical history in the past 3 months
* Currently perform overnight shift work
* Regularly eat within a \<10.5-hour period each day
* Lost or gained more than 4% of weight in the past 2 months
* Traveled more than 2 time zones away in the 2 months prior to enrolling in this study
* Will travel outside the Central time zone in the 2 weeks prior to testing
* Will travel more than 1 time zone away during this study
* Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements
30 Years
70 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Courtney M Peterson
Associate Professor
Principal Investigators
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Courtney M. Peterson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300001180
Identifier Type: -
Identifier Source: org_study_id
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