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Completed

NCT Number: NCT03527368

The Time-Restricted Intake of Meals 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.

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Key information

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins ProHealth

Baltimore, Maryland, 21207, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-restricted feeding

Behavioral

Participants consume food earlier in the day

Usual feeding pattern

Behavioral

Participants consume food later in the day

Primary outcomes

  1. Weight Change

    Time frame: 12 weeks

    Weight change will be measured in kg

Secondary outcomes

  1. Fasting glucose

    Time frame: 12 weeks

    Change in fasting glucose

  2. HOMA-IR

    Time frame: 12 weeks

    Change in HOMA-IR

  3. AUC glucose

    Time frame: 12 weeks

    Area-under-the-curve for glucose on OGTT

  4. Glycated albumin

    Time frame: 12 weeks

    Glycated albumin

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: TRIM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 17, 2018
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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