PreDiabetes, Obesity
Conditions
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.
Interventions
BEHAVIORALTime-restricted feeding
Participants consume food earlier in the day
BEHAVIORALUsual feeding pattern
Participants consume food later in the day
Sponsors
American Heart Association
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change | 12 weeks | Weight change will be measured in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed