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Early vs Late Dinner for Obesity (DTOP Trial)
N/A
Recruiting
Led By Stephanie T Chung, MBBS
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes
For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks
Awards & highlights
DTOP Trial Summary
This trial will study how the timing of our food intake in relation to our body's internal clock affects our weight and metabolism.
Who is the study for?
Adults aged 18-50 with obesity and prediabetes (BMI ≥30 kg/m2) or healthy subjects with a BMI of 18-24.9 can join this study. Participants must understand the procedures, not have metabolic disorders, gastrointestinal surgeries, severe sleep issues, or be on certain medications that affect metabolism.Check my eligibility
What is being tested?
The trial is testing how eating dinner early versus late affects weight and metabolism in relation to our body's natural clock. It uses precise methods to measure the body's circadian rhythm and its impact on health when aligning meal times.See study design
What are the potential side effects?
There may be minimal side effects as this study primarily involves changing dinner times rather than medication intake; however, discomfort from adhering to new eating schedules could occur.
DTOP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18-50 years old, overweight, and have prediabetes.
Select...
I am a healthy adult aged 18-50 with a BMI between 18-24.9.
DTOP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24-hour total fat oxidation
Secondary outcome measures
14-hour post-dinner cumulative dietary fat oxidation
4-hour post-prandial area-under-the-curve (AUC) glucose levels
4-hour post-prandial area-under-the-curve insulin levels
DTOP Trial Design
2Treatment groups
Experimental Treatment
Group I: Late Dinner FirstExperimental Treatment4 Interventions
Participants will be served dinner and a stable isotope of oral [2H31] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.
Group II: Early Dinner FirstExperimental Treatment4 Interventions
Participants will be served dinner and a stable isotope of oral [2H31] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,465 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,560 Total Patients Enrolled
Stephanie T Chung, MBBSPrincipal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently in a program to lose weight.I am taking medication that can affect my body's daily rhythms.I have a condition that could block my digestive system.I regularly use medications for anxiety, sleep, or pain.You have traveled across more than one time zone within three months before and during the study.I have severe heartburn that worsens if I eat late.I have diabetes or take diabetes medication other than metformin.I am on medication that could affect my metabolism.I have a history of an inherited metabolic disorder.I have difficulty swallowing.You work during the night.I have had surgery on my digestive system.I have kidney disease.You are currently smoking.You regularly go to bed after 1:00 AM or wake up after 5:00 AM, according to a sleep questionnaire or a specific test for melatonin levels.Your hemoglobin level is less than 10 grams per deciliter.I have a condition affecting my metabolism or heart.You need to have a strong MRI scan while using the ingestible thermosensor.I am in or past menopause, confirmed by hormone levels or irregular periods.I am 18-50 years old, overweight, and have prediabetes.I have lost or gained more than 5% of my body weight in the last 3 months.You have had important problems with getting medicine through a vein in the past.Your Hemoglobin A1c level is higher than 5.7% for NWH cohort or 6.5% for OPD cohort.You have strict dietary requirements, such as being a vegetarian, following a kosher diet, or having food allergies.You are a professional or college-level athlete.I am a healthy adult aged 18-50 with a BMI between 18-24.9.I have had weight loss surgery in the past.My weight is either below 40 kg or above 180 kg.I have a sleep disorder like insomnia or sleep apnea that's not treated.
Research Study Groups:
This trial has the following groups:- Group 1: Early Dinner First
- Group 2: Late Dinner First
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Prediabetes Patient Testimony for trial: Trial Name: NCT05745441 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research protocol permissible for minors?
"This medical trial is open to individuals aged 18 and above, up to the age of 50."
Answered by AI
Is enrollment for this research endeavor accessible to individuals at the present moment?
"Per the information on clinicaltrials.gov, this particular medical trial is not presently recruiting participants. Originally posted in March of 2023 and most recently updated two days ago, it appears that recruitment has come to a close; however, there are 1924 other trials accepting candidates at present time."
Answered by AI
Is participation in this experiment open to the public?
"To be eligible for this study, individuals must have prediabetes and fall between ages 18 to 50. Currently, the trial is seeking 32 participants."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins Bayview Medical Center
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Ok so I I saw a video on doing trials and I can’t afford to put food on the table right k now. Really need some income.
PatientReceived no prior treatments
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