HealthyDT2NCT04671797
Dinner Time 2: Effect of Delayed Eating or Sleeping on Metabolism
A study testing Early dinner, Late Dinner and Late Dinner + Late Sleep in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study examines the acute impact of eating an "early" versus "late" dinner. "Early" and "late" will be customized to individuals based on the individuals' own circadian rhythms. Healthy adults will have the adults' circadian rhythm assessed by measuring the adults' dim light melatonin onset (DLMO). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Early dinner, Late Dinner and Late Dinner + Late Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female adult volunteers, age 18-30
- BMI 18-30 kg/m2
- Accustomed to a bedtime before 1:00 A.M. or having mid-sleep on free days (MSF) earlier than 5 A.M. from the Munich Chronotype Questionnaire (MCTQ) (to exclude extreme late chronotypes)
- Exclusions:
- Sleep disorder including insomnia, sleep apnea, circadian rhythm disorder, restless leg syndrome, narcolepsy, shift work sleep disorder
- Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bed time.
Show all 17Show fewer
- Chronic use of sedative hypnotics, anxiolytics, opiates
- Use of medications that can affect circadian rhythm (beta blockers, melatonin)
- Active smoking (may interfere with metabolism and Clinical Research Unit (CRU) activities)
- Diabetes (type 1 or 2)
- HbA1c point of care >= 6.5%
- Kidney disease
- Any known history of an inherited metabolic disorder
- Pregnant or lactating female (pregnancy test will be required)
- Professional or collegiate athlete
- Travel across >1 time zone within a 3-month period before and during the protocol
- DLMO > 24:00 will be excluded from the metabolic study visits
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
This study examines the acute impact of eating an "early" versus "late" dinner. "Early" and "late" will be customized to individuals based on the individuals' own circadian rhythms. Healthy adults will have the adults' circadian rhythm assessed by measuring the adults' dim light melatonin onset (DLMO). Based on the timing of DLMO, participants will be randomized to eating dinner before DLMO or after DLMO. The investigators will also compare the effects of delaying sleep relative to dinner time. Participants will eat meals in the laboratory and have serial plasma samples collected to examine profiles of free fatty acids, glucose, insulin, triglycerides, and oxidation of dietary fat.
Read the detailed description
Obesity is a worldwide health problem. Recent studies suggest that the timing of meals may be critically important for weight control and cardiovascular health. Consuming calories later in the day is associated with greater risks of obesity, metabolic syndrome, and cardiovascular disease. Interventional diet studies also show more effective weight loss with early, rather than later eating. The investigators conducted a randomized crossover study comparing the metabolic effect of a "routine" dinner (RD,18:00) with that of an isocaloric "late" dinner (LD, 22:00) in 20 healthy volunteers. The investigators recently published results of this study, which the investigators now refer to as "Dinner Time 1". Relative to RD, LD increased post-dinner glucose peak by ~18% and lowered palmitate oxidation by ~10%. However, it is still unclear whether LD-induced impaired metabolic dysfunction is caused by eating at the "wrong" time relative to the body's central circadian clock, or it is caused by eating too close to bedtime, when sleep reduces metabolic demands.
To address this question, the investigators are now enlarging the scope of the present study, which the investigators now refer to as "Dinner Time 2". In Dinner Time 2, the investigators will examine the impacts of early dinner, late dinner, and the impact of delaying sleep after late dinner. The investigators will compare (1) the impact of early dinner time with later dinner time relative to DLMO with a routine sleep time; and (2) the impact of routine bedtime with late bedtime with a fixed late dinner time.
The investigators will examine the nocturnal and next-morning metabolic profile in a 3-arm randomized crossover study of healthy volunteers:
Arm 1: Early Dinner (dinner at DLMO-3, sleep at DLMO+2) Arm 2: Late Dinner (dinner at DLMO+1, sleep at DLMO+2) Arm 3: Late Dinner/Late Sleep (dinner at DLMO+1, sleep at DLMO+6)
The investigators will use serial blood sampling to assess the metabolic response to meals, and use an ingested stable isotope [(2H31)palmitate] tracer to calculate the oxidation of dietary lipid eaten at the different times.
- Conditions
- Healthy
- Being tested
- Early dinner, Late Dinner, Late Dinner + Late Sleep
- Keywords
- healthy volunteers, fat oxidation, sleep, circadian, glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early dinnerBehavioural
Dinner at DLMO-3, sleep at DLMO+2
Late DinnerBehavioural
Dinner at DLMO+1, sleep at DLMO+2
Late Dinner + Late SleepBehavioural
Dinner at DLMO+1, sleep at DLMO+6
| Study group | Role | What they receive |
|---|---|---|
| Early Dinner first | Experimental | 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. Receives: Behavioral: Early dinner; Behavioral: Late Dinner; Behavioral: Late Dinner + Late Sleep |
| Late Dinner first | Experimental | 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. Receives: Behavioral: Early dinner; Behavioral: Late Dinner; Behavioral: Late Dinner + Late Sleep |
| Late Dinner + Late Sleep first | Experimental | 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. Receives: Behavioral: Early dinner; Behavioral: Late Dinner; Behavioral: Late Dinner + Late Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glucose (mg/dl)
Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (6)
Change in Free Fatty Acids (FFA, mmol/L)
Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.
Measured: Baseline, 4 weeks and 8 weeks
Change in Insulin (mcU/ml)
Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.
Measured: Baseline, 4 weeks and 8 weeks
Change in Triglycerides (mg/dl)
Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.
Measured: Baseline, 4 weeks and 8 weeks
Change in Oxidation of palmitate (percent of isotope enrichment)
Serial blood samples taken during visit (14 samples per visit).
Measured: Baseline, 4 weeks and 8 weeks
Change in melatonin [Dim light melatonin onset (DLMO)]
Serial saliva samples taken during visit, 14 samples taken over 7 hours (one sample every 30 minutes) to access change in melatonin levels (pg/ml) over 7 hours.
Measured: At 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)
Sleep architecture
Sleep stage distribution by EEG during each of the 3 sleep studies.
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Jan 2021
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Jonathan Jun, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671797
- Sponsor's protocol ID
- IRB00156120-2
- Acronym
- DT2
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2020
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We 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 32525525
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dinner Time 2: Effect of Delayed Eating or Sleeping on Metabolism
- ClinicalTrials.gov ID
- NCT04671797
- Acronym / sponsor ID
- DT2 / IRB00156120-2
- Conditions
- Healthy
- Keywords
- healthy volunteers, fat oxidation, sleep, circadian, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Arkansas, National Marrow Donor Program
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 17 Dec 2020 (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.
This study examines the acute impact of eating an "early" versus "late" dinner. "Early" and "late" will be customized to individuals based on the individuals' own circadian rhythms. Healthy adults will have the adults' circadian rhythm assessed by measuring the adults' dim light melatonin onset (DLMO). Based on the timing of DLMO, participants will be randomized to eating dinner before DLMO or after DLMO. The investigators will also compare the effects of delaying sleep relative to dinner time. Participants will eat meals in the laboratory and have serial plasma samples collected to examine profiles of free fatty acids, glucose, insulin, triglycerides, and oxidation of dietary fat.
Detailed description
Obesity is a worldwide health problem. Recent studies suggest that the timing of meals may be critically important for weight control and cardiovascular health. Consuming calories later in the day is associated with greater risks of obesity, metabolic syndrome, and cardiovascular disease. Interventional diet studies also show more effective weight loss with early, rather than later eating. The investigators conducted a randomized crossover study comparing the metabolic effect of a "routine" dinner (RD,18:00) with that of an isocaloric "late" dinner (LD, 22:00) in 20 healthy volunteers. The investigators recently published results of this study, which the investigators now refer to as "Dinner Time 1". Relative to RD, LD increased post-dinner glucose peak by ~18% and lowered palmitate oxidation by ~10%. However, it is still unclear whether LD-induced impaired metabolic dysfunction is caused by eating at the "wrong" time relative to the body's central circadian clock, or it is caused by eating too close to bedtime, when sleep reduces metabolic demands.
To address this question, the investigators are now enlarging the scope of the present study, which the investigators now refer to as "Dinner Time 2". In Dinner Time 2, the investigators will examine the impacts of early dinner, late dinner, and the impact of delaying sleep after late dinner. The investigators will compare (1) the impact of early dinner time with later dinner time relative to DLMO with a routine sleep time; and (2) the impact of routine bedtime with late bedtime with a fixed late dinner time.
The investigators will examine the nocturnal and next-morning metabolic profile in a 3-arm randomized crossover study of healthy volunteers:
Arm 1: Early Dinner (dinner at DLMO-3, sleep at DLMO+2) Arm 2: Late Dinner (dinner at DLMO+1, sleep at DLMO+2) Arm 3: Late Dinner/Late Sleep (dinner at DLMO+1, sleep at DLMO+6)
The investigators will use serial blood sampling to assess the metabolic response to meals, and use an ingested stable isotope [(2H31)palmitate] tracer to calculate the oxidation of dietary lipid eaten at the different times.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Dinner first | Experimental | Behavioral: Early dinner, Behavioral: Late Dinner, Behavioral: Late Dinner + Late SleepParticipants 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. |
| Late Dinner first | Experimental | Behavioral: Early dinner, Behavioral: Late Dinner, Behavioral: Late Dinner + Late SleepParticipants 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. |
| Late Dinner + Late Sleep first | Experimental | Behavioral: Early dinner, Behavioral: Late Dinner, Behavioral: Late Dinner + Late SleepParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy male and female adult volunteers, age 18-30
- BMI 18-30 kg/m2
- Accustomed to a bedtime before 1:00 A.M. or having mid-sleep on free days (MSF) earlier than 5 A.M. from the Munich Chronotype Questionnaire (MCTQ) (to exclude extreme late chronotypes)
- Sleep disorder including insomnia, sleep apnea, circadian rhythm disorder, restless leg syndrome, narcolepsy, shift work sleep disorder
- Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bed time.
Key exclusion criteria (0 listed)
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 at DLMO-3, sleep at DLMO+2 | Behavioural | Early Dinner first, Late Dinner + Late Sleep first, Late Dinner first |
| Late DinnerDinner at DLMO+1, sleep at DLMO+2 | Behavioural | Early Dinner first, Late Dinner + Late Sleep first, Late Dinner first |
| Late Dinner + Late SleepDinner at DLMO+1, sleep at DLMO+6 | Behavioural | Early Dinner first, Late Dinner + Late Sleep first, Late Dinner first |
Primary outcome
Change in Glucose (mg/dl)
Time frame: Baseline, 4 weeks and 8 weeks
Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.
6 secondary outcomes
Change in Free Fatty Acids (FFA, mmol/L)
Time frame: Baseline, 4 weeks and 8 weeks
Change in Insulin (mcU/ml)
Time frame: Baseline, 4 weeks and 8 weeks
Change in Triglycerides (mg/dl)
Time frame: Baseline, 4 weeks and 8 weeks
Change in Oxidation of palmitate (percent of isotope enrichment)
Time frame: Baseline, 4 weeks and 8 weeks
Change in melatonin [Dim light melatonin onset (DLMO)]
Time frame: At 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)
Sleep architecture
Time frame: Baseline, 4 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We 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. This study is not recruiting at the moment.
Jonathan Jun, MD principal investigator
Johns Hopkins University
1 site 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 Late Dinner + Late Sleep in people with Healthy, run by Johns Hopkins University at 1 site 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 17 inclusion and 0 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: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glucose (mg/dl) (time frame: Baseline, 4 weeks and 8 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 NCT04671797, which also lists 1 linked publication.
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 4 Feb 2026.