The Time-Restricted Intake of Meals Study

Study Overview
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Brief Summary
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TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs. later in the day impacts weight and glucose homeostasis.

Official Title
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The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study

Conditions
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PreDiabetes, Obesity

Intervention / Treatment
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* Behavioral: Time-restricted feeding
* Behavioral: Usual feeding pattern


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prediabetes defined by HbA1c 5.7-6.4%, or type 2 diabetes with HbA1c 6.5-6.9% Class I-III obesity (BMI 30-50 kg/m2) If on medications for hypertension, stable regimen for at least past 6 months Willingness to adjust timing of feeding Willingness and ability to eat study diet and nothing else during run-in and intervention Willingness to complete measurement procedures Exclusion Criteria: Moderate to severe obstructive sleep apnea Shift work; Other sleep/circadian disorders: e.g., circadian phase delay or phase advance; restless legs syndrome, insomnia, narcolepsy, habitual sleep <6 hours/night Routinely ate within compressed time window in the past year (e.g., routinely eats all food within an 10-hour or narrower window, follows an intermittent fasting protocol) Renal dysfunction (estimated Glomerular Filtration Rate (GFR) <30 using the simplified Chronic Kidney Disease (CKD) Epidemiology Collaboration (EPI) equation 34) Use of glucose-lowering medications, weight loss medications, medications for sleep disorders (sedative/hypnotic drugs, stimulants), lithium, systemic corticosteroids, diuretics, blood thinners requiring regular monitoring (e.g. warfarin), anti-psychotic drugs and antiretroviral therapy Body weight >400 pounds (limitation of facility scales) >1 drink per day of alcohol Active substance use disorder or significant psychiatric/psychologic disorder that would interfere with participation Significant food allergies, preferences, intolerances, or dietary supplements that would interfere with diet adherence Weight loss or gain of ≥5% during past 6 months Pregnant, planning to become pregnant, or breastfeeding Planning to start a weight loss program Planning to leave the area prior to end of study Current participation in another clinical trial Cancer diagnosis requiring active treatment in past two years or planned treatment (with exception of localized non-melanoma skin cancer) Active inflammatory bowel disease, malabsorption, or history of major gastrointestinal surgery involving bowel resection Myocardial infarction or stroke in past 6 months Prior bariatric surgery Any serious illness that would interfere with participation Other conditions or situations at the discretion of the PI

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time-restricted feeding<br> | Behavioral: Time-restricted feeding<br>* Participants consume food earlier in the day<br>|
| Other: Usual feeding pattern<br>Comparison | Behavioral: Usual feeding pattern<br>* Participants consume food later in the day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | Weight change will be measured in kg | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Change in fasting glucose | 12 weeks | 
| HOMA-IR | Change in HOMA-IR | 12 weeks | 
| AUC glucose | Area-under-the-curve for glucose on OGTT | 12 weeks | 
| Glycated albumin | Glycated albumin | 12 weeks |