PreDiabetesDTOPNCT05745441
Dinner Time for Obesity and Prediabetes
A study testing Early Dinner, Late Dinner and Early Dinner tracer in people with PreDiabetes and Obesity, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Obesity, Healthy
- What is being tested?
- Early Dinner, Late Dinner and Early Dinner tracer
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively
- For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes
- All participants must be able to understand study procedures, to comply with the procedures for the entire length of the study and be fully mobile.
Who cannot join
- Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy
- Night shift work
- Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00
- Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime
- Active smoking
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Show all 32Show fewer
- Diabetes (type 1 or 2) or on any diabetes medications besides metformin
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease)
- Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort
- Hemoglobin < 10 g/dL
- Self-reported kidney disease
- Any known history of an inherited metabolic disorder
- Pregnant or lactating female (pregnancy test will be required prior to metabolic visits)
- Peri-menopausal or post-menopausal female as determined by follicle stimulating hormone of > 30 mIU/mL or fewer than 3 menstrual periods in 6 months
- Professional or collegiate athlete
- Participants who have travelled across time zones must have adequate time to recover from jet lag prior to enrollment (i.e., at least 3 days per time zone). Travel across >1 time zone after enrollment in the study will not be permitted.
- Weight less than 40 kg or more than 180 kg
- Gastrointestinal disorders that can lead to obstruction of the digestive tract (i.e. diverticular disease, history of bowel obstruction, inflammatory bowel disease, motility disorder)
- History of any surgical procedures in the gastrointestinal tract.
- Swallowing disorders
- Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
- Chronic use of sedative hypnotics, anxiolytics, opiates
- Use of medications that can affect circadian rhythm (beta blockers, melatonin)
- Presence of a cardiac pacemaker or other implanted electro-medical devices
- Those who have to undergo strong electromagnetic field during the period of use of the ingestible thermosensor (i.e. MRI)
- Weight loss or gain of ≥ 5% of total body weight over the preceding 3 months
- Currently participating in a weight loss program
- Prior bariatric surgery
- Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
- History of significant intravenous access issues
- Non-English speaking individuals: The complexity of the instructions for various components of the study would make the study procedures difficult to follow in the setting of a language barrier.
- Other conditions or situations at the discretion of the PI
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Athena Mavronis, 410-550-4588, amavron1@jhmi.edu
Jonathan Jun, MD, 410-550-0115, jjun2@jhmi.edu
- Not yet recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Stephanie T Chung, MBBS, 240-479-8137, stephanie.chung@nih.gov
Lilian Mabundo, RN, MSN, 240-383-9379, lilian.mabundo@nih.gov
About this study
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.
Read the detailed description
This is a randomized, cross-over study that examines the metabolic impact of early vs late dinner, as defined by proximity of food intake to an individual's biological night as determined by dim light melatonin onset (DLMO) in normal-weight, healthy adult volunteers and in adults with obesity and prediabetes. Each participant will first undergo circadian phenotyping at the Johns Hopkins Bayview Clinical Research Unit (Baltimore, Maryland), with assessment of DLMO and core body temperature profile, as well as wrist actigraphy. Thereafter, participants will be crossover randomized to (1) a 24-hour metabolic chamber protocol where dinner is eaten 3 hours before DLMO (early dinner), or (2) a 24-hour metabolic chamber protocol where dinner is 1 hour eaten after DLMO (late dinner), both to be performed at the NIH Metabolic Clinical Research Unit (Bethesda, Maryland). The timing and nutritional contents of all meals, as well as sleep timing and duration, will be held constant. Oral [2H31] palmitate will be given with each dinner condition to quantify dietary fat oxidation. The 2 dinner conditions will occur in random order, with a 3- to 4-week washout period.
The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants. At this time (5/2023) the investigators are focusing on the NWH group.
- Conditions
- PreDiabetes, Obesity, Healthy
- Being tested
- Early Dinner, Late Dinner, Early Dinner tracer, Late Dinner tracer
- Keywords
- circadian, sleep, glucose, metabolism
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early DinnerBehavioural
Dinner before DLMO
Late DinnerBehavioural
Dinner after DLMO
Early Dinner tracerDrug
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner before DLMO
Late Dinner tracerDrug
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner after DLMO
| Study group | Role | What they receive |
|---|---|---|
| Early Dinner First | Experimental | 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. Receives: Behavioral: Early Dinner; Behavioral: Late Dinner; Drug: Early Dinner tracer; Drug: Late Dinner tracer |
| Late Dinner First | Experimental | 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. Receives: Behavioral: Early Dinner; Behavioral: Late Dinner; Drug: Early Dinner tracer; Drug: Late Dinner tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour total fat oxidation
Within-subject difference in total fat oxidation between early dinner and late dinner conditions.
Measured: baseline, 4 weeks
Secondary outcomes (3)
4-hour post-prandial area-under-the-curve (AUC) glucose levels
Within-subject difference in post-prandial AUC glucose levels between early dinner and late dinner conditions.
Measured: baseline, 4 weeks
4-hour post-prandial area-under-the-curve insulin levels
Within-subject difference in post-prandial AUC insulin levels between early dinner and late dinner conditions.
Measured: baseline, 4 weeks
14-hour post-dinner cumulative dietary fat oxidation
Within-subject difference in dietary fat oxidation between early dinner and late dinner conditions.
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start5 Jul 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Jun, MD, Principal investigator, Johns Hopkins UniversityStephanie T Chung, MBBS, Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745441
- Sponsor's protocol ID
- IRB00301239
- Other IDs
- K23DK133690
- Acronym
- DTOP
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will provide raw data (without identifying information) to journals or other researchers upon request.
Publications
Gu C, Brereton N, Schweitzer A, Cotter M, Duan D, Borsheim E, Wolfe RR, Pham LV, Polotsky VY, Jun JC. Metabolic Effects of Late Dinner in Healthy Volunteers-A Randomized Crossover Clinical Trial. J Clin Endocrinol Metab. 2020 Aug 1;105(8):2789-802. doi: 10.1210/clinem/dgaa354.
PubMed 32525525Duan D, Gu C, Polotsky VY, Jun JC, Pham LV. Effects of Dinner Timing on Sleep Stage Distribution and EEG Power Spectrum in Healthy Volunteers. Nat Sci Sleep. 2021 May 14;13:601-612. doi: 10.2147/NSS.S301113. eCollection 2021.
PubMed 34017207
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dinner Time for Obesity and Prediabetes
- ClinicalTrials.gov ID
- NCT05745441
- Acronym / sponsor ID
- DTOP / IRB00301239
- Conditions
- PreDiabetes, Obesity, Healthy
- Keywords
- circadian, sleep, glucose, metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.
Detailed description
This is a randomized, cross-over study that examines the metabolic impact of early vs late dinner, as defined by proximity of food intake to an individual's biological night as determined by dim light melatonin onset (DLMO) in normal-weight, healthy adult volunteers and in adults with obesity and prediabetes. Each participant will first undergo circadian phenotyping at the Johns Hopkins Bayview Clinical Research Unit (Baltimore, Maryland), with assessment of DLMO and core body temperature profile, as well as wrist actigraphy. Thereafter, participants will be crossover randomized to (1) a 24-hour metabolic chamber protocol where dinner is eaten 3 hours before DLMO (early dinner), or (2) a 24-hour metabolic chamber protocol where dinner is 1 hour eaten after DLMO (late dinner), both to be performed at the NIH Metabolic Clinical Research Unit (Bethesda, Maryland). The timing and nutritional contents of all meals, as well as sleep timing and duration, will be held constant. Oral [2H31] palmitate will be given with each dinner condition to quantify dietary fat oxidation. The 2 dinner conditions will occur in random order, with a 3- to 4-week washout period.
The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants. At this time (5/2023) the investigators are focusing on the NWH group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Dinner First | Experimental | Behavioral: Early Dinner, Behavioral: Late Dinner, Drug: Early Dinner tracer, Drug: Late Dinner tracerParticipants 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. |
| Late Dinner First | Experimental | Behavioral: Early Dinner, Behavioral: Late Dinner, Drug: Early Dinner tracer, Drug: Late Dinner tracerParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively
- For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes
- All participants must be able to understand study procedures, to comply with the procedures for the entire length of the study and be fully mobile.
Key exclusion criteria (32 listed)
- Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy
- Night shift work
- Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00
- Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime
- Active smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early DinnerDinner before DLMO | Behavioural | Early Dinner First, Late Dinner First |
| Late DinnerDinner after DLMO | Behavioural | Early Dinner First, Late Dinner First |
| Early Dinner tracerStable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner before DLMO | Drug | Early Dinner First, Late Dinner First |
| Late Dinner tracerStable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner after DLMO | Drug | Early Dinner First, Late Dinner First |
Primary outcome
24-hour total fat oxidation
Time frame: baseline, 4 weeks
Within-subject difference in total fat oxidation between early dinner and late dinner conditions.
3 secondary outcomes
4-hour post-prandial area-under-the-curve (AUC) glucose levels
Time frame: baseline, 4 weeks
4-hour post-prandial area-under-the-curve insulin levels
Time frame: baseline, 4 weeks
14-hour post-dinner cumulative dietary fat oxidation
Time frame: baseline, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 32525525Gu C, Brereton N, Schweitzer A, Cotter M, Duan D, Borsheim E, Wolfe RR, Pham LV, Polotsky VY, Jun JC. Metabolic Effects of Late Dinner in Healthy Volunteers-A Randomized Crossover Clinical Trial. J Clin Endocrinol Metab. 2020 Aug 1;105(8):2789-802. doi: 10.1210/clinem/dgaa354.
- Background: PubMed 34017207Duan D, Gu C, Polotsky VY, Jun JC, Pham LV. Effects of Dinner Timing on Sleep Stage Distribution and EEG Power Spectrum in Healthy Volunteers. Nat Sci Sleep. 2021 May 14;13:601-612. doi: 10.2147/NSS.S301113. eCollection 2021.
- Screening Survey for DTOPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will provide raw data (without identifying information) to journals or other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Jun, MD principal investigator
Johns Hopkins University
Stephanie T Chung, MBBS principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Dinner, Late Dinner and Early Dinner tracer in people with PreDiabetes and Obesity, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athena Mavronis ((410) 550-4588, amavron1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour total fat oxidation (time frame: baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.