The Time-Restricted Intake of Meals Study

Obesity Clinical Trial

— TRIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527368
• Other study ID #: IRB00155640
• Secondary ID: 17SFRN33590069
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins ProHealth	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Weight change will be measured in kg	12 weeks
Secondary	Fasting glucose	Change in fasting glucose	12 weeks
Secondary	HOMA-IR	Change in HOMA-IR	12 weeks
Secondary	AUC glucose	Area-under-the-curve for glucose on OGTT	12 weeks
Secondary	Glycated albumin	Glycated albumin	12 weeks