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The Time-Restricted Intake of Meals Study (TRIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527368
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : January 25, 2021
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Johns Hopkins University

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
PreDiabetes Obesity Behavioral: Time-restricted feeding Behavioral: Usual feeding pattern Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 24, 2018
Actual Primary Completion Date : December 23, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Time-restricted feeding Behavioral: Time-restricted feeding
Participants consume food earlier in the day

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




Primary Outcome Measures :
  1. Weight Change [ Time Frame: 12 weeks ]
    Weight change will be measured in kg


Secondary Outcome Measures :
  1. Oral glucose tolerance test (OGTT) [ Time Frame: 12 weeks ]
    Change in 2-hour glucose on OGTT

  2. Blood pressure [ Time Frame: 12 weeks ]
    24-hour ambulatory systolic blood pressure

  3. Blood pressure [ Time Frame: 12 weeks ]
    24-hour ambulatory diastolic blood pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 30-39.9 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527368


Locations
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United States, Maryland
Johns Hopkins ProHealth
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
Johns Hopkins University
American Heart Association
Investigators
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Principal Investigator: Nisa Maruthur, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03527368    
Other Study ID Numbers: IRB00155640
17SFRN33590069 ( Other Grant/Funding Number: American Heart Association )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases