The Time-Restricted Intake of Meals Study

Not Applicable

Completed

• Conditions: PreDiabetes; Obesity

• Registration Number: NCT03527368
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-17
• Study Start: 2018-09-24
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight Change	12 weeks	Weight change will be measured in kg

Secondary Outcome Measures

Name	Time	Method
Fasting glucose	12 weeks	Change in fasting glucose
HOMA-IR	12 weeks	Change in HOMA-IR
AUC glucose	12 weeks	Area-under-the-curve for glucose on OGTT
Glycated albumin	12 weeks	Glycated albumin

Trial Locations

Locations (1)

Johns Hopkins ProHealth; 🇺🇸 Baltimore, Maryland, United States