CClinicalTrials.gg
CompletedNCT04671797DT2Updated Feb 4, 2026

Dinner Time 2: Effect of Delayed Eating or Sleeping on Metabolism

An interventional study of Early dinner and Late Dinner in Healthy, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Healthy

Keywords

  • healthy volunteers
  • fat oxidation
  • sleep
  • circadian
  • glucose
03

In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)

Exclusion criteria

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.
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Early Dinner first

    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.

    Behavioral: Early dinner · Behavioral: Late Dinner · Behavioral: Late Dinner + Late Sleep

  • Experimental
    Late Dinner first

    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.

    Behavioral: Early dinner · Behavioral: Late Dinner · Behavioral: Late Dinner + Late Sleep

  • Experimental
    Late Dinner + Late Sleep first

    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.

    Behavioral: Early dinner · Behavioral: Late Dinner · Behavioral: Late Dinner + Late Sleep

Interventions

  • BehavioralEarly dinner

    Dinner at DLMO-3, sleep at DLMO+2

  • BehavioralLate Dinner

    Dinner at DLMO+1, sleep at DLMO+2

  • BehavioralLate Dinner + Late Sleep

    Dinner at DLMO+1, sleep at DLMO+6

06

What researchers measure

Primary outcomes

  1. Change in Glucose (mg/dl)

    Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.

    Time frame: Baseline, 4 weeks and 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline, 4 weeks and 8 weeks

  2. Change in Insulin (mcU/ml)

    Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.

    Time frame: Baseline, 4 weeks and 8 weeks

  3. Change in Triglycerides (mg/dl)

    Serial blood samples taken during visit, 25 samples taken over 25 hours (One every hour) per visit.

    Time frame: Baseline, 4 weeks and 8 weeks

  4. Change in Oxidation of palmitate (percent of isotope enrichment)

    Serial blood samples taken during visit (14 samples per visit).

    Time frame: Baseline, 4 weeks and 8 weeks

  5. 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.

    Time frame: At 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)

  6. Sleep architecture

    Sleep stage distribution by EEG during each of the 3 sleep studies.

    Time frame: Baseline, 4 weeks and 8 weeks

07

Study locations

1 site
  • Johns Hopkins Bayview Medical Center
    Baltimore, Maryland 21224, United States
08

References and documents

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 ↗

Related links

Individual participant data

Plan to share: Yes — We will provide raw data (without identifying information) to journals or other researchers upon request.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04671797
Lead sponsor
Johns Hopkins University
Collaborators
University of Arkansas, National Marrow Donor Program
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Jan 15, 2021
Primary completion
Jun 19, 2025
Completion
Jun 19, 2025
Last update
Feb 4, 2026

Study contacts

Jonathan Jun, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion