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TRIM: The Time-Restricted Intake of Meals Study

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT03527368
Collaborator
American Heart Association (Other)
41
Enrollment
1
Location
2
Arms
15.2
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Time-restricted feeding
  • Behavioral: Usual feeding pattern
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study
Actual Study Start Date :
Sep 24, 2018
Actual Primary Completion Date :
Dec 23, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Time-restricted feeding

Behavioral: Time-restricted feeding
Participants consume food earlier in the day
Other: Usual feeding pattern

Comparison

Behavioral: Usual feeding pattern
Participants consume food later in the day

Outcome Measures

Primary Outcome Measures

  1. Weight Change [12 weeks]

    Weight change will be measured in kg

Secondary Outcome Measures

  1. Fasting glucose [12 weeks]

    Change in fasting glucose

  2. HOMA-IR [12 weeks]

    Change in HOMA-IR

  3. AUC glucose [12 weeks]

    Area-under-the-curve for glucose on OGTT

  4. Glycated albumin [12 weeks]

    Glycated albumin

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 69 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins ProHealth Baltimore Maryland United States 21207

Sponsors and Collaborators

  • Johns Hopkins University
  • American Heart Association

Investigators

  • Principal Investigator: Nisa Maruthur, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT03527368
Other Study ID Numbers:
  • IRB00155640
  • 17SFRN33590069
First Posted:
May 17, 2018
Last Update Posted:
May 17, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prediabetic State

Study Results

No Results Posted as of May 17, 2021