The Time-Restricted Intake of Meals Study (TRIM)

The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity; PreDiabetes
• Intervention / Treatment: Behavioral: Time-restricted feeding; Behavioral: Usual feeding pattern

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21207
      • Johns Hopkins ProHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	Weight change will be measured in kg	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Change in fasting glucose	12 weeks
HOMA-IR	Change in HOMA-IR	12 weeks
AUC glucose	Area-under-the-curve for glucose on OGTT	12 weeks
Glycated albumin	Glycated albumin	12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Nisa Maruthur, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2018
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: IRB00155640; 17SFRN33590069 (Other Grant/Funding Number: American Heart Association)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No