Clinical trial NCT03527368: The Time-Restricted Intake of Meals Study
Official title: The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2018-05-17
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight Change
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: 12 weeks
measure: HOMA-IR
timeFrame: 12 weeks
measure: AUC glucose
timeFrame: 12 weeks
measure: Glycated albumin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins ProHealth
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Nisa Maruthur, MD
role: PRINCIPAL_INVESTIGATOR
References: