Your session is about to expire
← Back to Search
Meal Timing and Sleep for Metabolic Health in Healthy Subjects (DT2 Trial)
N/A
Recruiting
Led By Jonathan Jun, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic use of sedative hypnotics, anxiolytics, opiates
Diabetes (type 1 or 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)
Awards & highlights
DT2 Trial Summary
This trial looks at the effects of eating dinner at different times, based on an individual's natural sleep cycle. Blood samples will be taken to measure how well the body processes different nutrients.
Who is the study for?
This trial is for healthy adults aged 18-30, with a BMI of 18-30 kg/m2 and normal sleep patterns (bedtime before 1:00 A.M. and mid-sleep before 5 A.M.). Participants should not be smokers or have conditions like diabetes, sleep disorders, GERD that affects eating near bedtime, or use medications affecting circadian rhythms.Check my eligibility
What is being tested?
The study investigates how the timing of dinner relative to one's own circadian rhythm impacts metabolism. It involves having an early or late dinner based on melatonin onset measurements and observing changes in metabolic markers like glucose and insulin levels.See study design
What are the potential side effects?
Since this trial involves only meal timing adjustments without any drugs or medical interventions, there are no direct side effects expected from participating in the study itself.
DT2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I regularly use medications for anxiety, sleep, or pain.
Select...
I have diabetes (type 1 or 2).
DT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Free Fatty Acids (FFA, mmol/L)
Change in Glucose (mg/dl)
Change in Insulin (mcU/ml)
+3 moreDT2 Trial Design
3Treatment groups
Experimental Treatment
Group I: Late Dinner firstExperimental Treatment3 Interventions
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a late dinner time (DLMO+1h) followed by a sleep study (DLMO+2h). This arm will cross-over to the other 2 arms in random order.
Group II: Late Dinner + Late Sleep firstExperimental Treatment3 Interventions
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a late dinner time (DLMO+1h) followed by delayed bedtime (DLMO+6h). This arm will cross-over to the other 2 arms in random order.
Group III: Early Dinner firstExperimental Treatment3 Interventions
Participants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at an early dinner time (DLMO-3h) followed by a sleep study (DLMO+2h). This arm will cross-over to the other 2 arms in random order.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,099 Total Patients Enrolled
University of ArkansasOTHER
486 Previous Clinical Trials
150,287 Total Patients Enrolled
Jonathan Jun, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heartburn that prevents me from eating late.I regularly use medications for anxiety, sleep, or pain.Your body mass index (BMI) falls between 18 and 30.I am a healthy adult between 18 and 30 years old.I have a history of an inherited metabolic disorder.I have diabetes (type 1 or 2).I have severe heartburn that makes it hard to eat before bed.You are a professional or college athlete.You have a HbA1c point of care > 6.I have a sleep disorder such as insomnia or sleep apnea.I have not traveled across more than one time zone in the last 3 months and won't during the study.I am taking medications that could affect my sleep-wake cycle.I have kidney disease.Smoking cigarettes can interfere with the body's metabolism and the ability to carry out clinical research.
Research Study Groups:
This trial has the following groups:- Group 1: Late Dinner first
- Group 2: Late Dinner + Late Sleep first
- Group 3: Early 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.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT04671797 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals above the age of eighty-five eligible for this clinical examination?
"All participants of this clinical trial must be over the age of majority and below 30 years old."
Answered by AI
To whom is this experimental intervention available?
"This clinical trial is seeking 66 volunteers between the ages of 18 and 30 who are deemed healthy subjects (hs). Additionally, applicants must fit within all of the following specifications: male or female adults with no current Gastroesophageal reflux disease that impedes their ability to eat late at night, active smokers (as this may interfere with metabolic processes), sleeping disorders such as insomnia, sleep apnea, circadian rhythm disorder etc., chronic use of anxiolytics and opiates; BMI between 18-30 kg/m2; acclimatised to a bedtime before 1 A.M.; mid-sleep on free days"
Answered by AI
Are there still available slots for enrolment in this trial?
"According to the clinicaltrials.gov listing, this investigation is currently recruiting participants and was first published on January 15th 2021 with a recent update occurring on September 8th 2022."
Answered by AI
How many people have joined this medical trial thus far?
"Affirmative. Information accessible on clinicaltrials.gov confirms that this research, which was first posted to the database on January 15th 2021, is currently seeking participants. A total of 66 individuals need to be enrolled from two distinct sites."
Answered by AI
Who else is applying?
What state do they live in?
California
Pennsylvania
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Bayview Medical Center
Johns Hopkins
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I been trying to get into any healthy trial.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Johns Hopkins: < 48 hours
Average response time
- < 2 Days
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger