The Time-Restricted Intake of Meals Study (TRIM)

Johns Hopkins University

Status

Completed

Conditions

Obesity

PreDiabetes

Treatments

Behavioral: Usual feeding pattern

Behavioral: Time-restricted feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT03527368

17SFRN33590069 (Other Grant/Funding Number)

IRB00155640

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

21 to 69 years old

Volunteers

Accepts Healthy Volunteers

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