Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03527368
Other study ID # IRB00155640
Secondary ID 17SFRN33590069
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2