The Time-Restricted Intake of Meals Study (TRIM)

Johns Hopkins University logo

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

41 participants in 2 patient groups

Time-restricted feeding
Experimental group
Treatment:
Behavioral: Time-restricted feeding
Usual feeding pattern
Other group
Description:
Comparison
Treatment:
Behavioral: Usual feeding pattern

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems