The Time-Restricted Intake of Meals Study

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2019-12-31

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.

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Detailed Description

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Conditions

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PreDiabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Time-restricted feeding

Group Type EXPERIMENTAL

Time-restricted feeding

Intervention Type BEHAVIORAL

Participants consume food earlier in the day

Usual feeding pattern

Comparison

Group Type OTHER

Usual feeding pattern

Intervention Type BEHAVIORAL

Participants consume food later in the day

Interventions

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Time-restricted feeding

Participants consume food earlier in the day

Intervention Type BEHAVIORAL

Usual feeding pattern

Participants consume food later in the day

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes