NCT03527368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

May 4, 2018

Last Update Submit

May 13, 2021

Conditions

PreDiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • Weight Change

    Weight change will be measured in kg

    12 weeks

Secondary Outcomes (4)

  • Fasting glucose

    12 weeks

  • HOMA-IR

    12 weeks

  • AUC glucose

    12 weeks

  • Glycated albumin

    12 weeks

Study Arms (2)

Time-restricted feeding

EXPERIMENTAL
Behavioral: Time-restricted feeding

Usual feeding pattern

OTHER

Comparison

Behavioral: Usual feeding pattern

Interventions

Time-restricted feedingBEHAVIORAL

Participants consume food earlier in the day

Time-restricted feeding
Usual feeding patternBEHAVIORAL

Participants consume food later in the day

Usual feeding pattern

Eligibility Criteria

Age21 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins ProHealth

Baltimore, Maryland, 21207, United States

Location

Related Publications (2)

  • Duan D, Pham LV, Jun JC, Turkson-Ocran RA, Pilla SJ, Clark JM, Maruthur NM. Effects of time-restricted eating on actigraphy-derived sleep parameters: post hoc analysis of a randomized, isocaloric feeding study. Sleep. 2025 Sep 9;48(9):zsaf089. doi: 10.1093/sleep/zsaf089.

    PMID: 40241264DERIVED

  • Maruthur NM, Pilla SJ, White K, Wu B, Maw MTT, Duan D, Turkson-Ocran RA, Zhao D, Charleston J, Peterson CM, Dougherty RJ, Schrack JA, Appel LJ, Guallar E, Clark JM. Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity : A Randomized Controlled Trial. Ann Intern Med. 2024 May;177(5):549-558. doi: 10.7326/M23-3132. Epub 2024 Apr 19.

    PMID: 38639542DERIVED

MeSH Terms

Conditions

Prediabetic StateObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nisa Maruthur, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 17, 2018

Study Start

September 24, 2018

Primary Completion

December 23, 2019

Study Completion

December 31, 2019

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations

US(1)