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Completed

NCT Number: NCT04671797

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

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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.
  • 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

Treatment and study plan

Early dinner

Behavioral

Dinner at DLMO-3, sleep at DLMO+2

Late Dinner

Behavioral

Dinner at DLMO+1, sleep at DLMO+2

Late Dinner + Late Sleep

Behavioral

Dinner at DLMO+1, sleep at DLMO+6

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Free Fatty Acids (FFA, mmol/L)

    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.

  2. Change in Insulin (mcU/ml)

    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.

  3. Change in Triglycerides (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.

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

    Time frame: Baseline, 4 weeks and 8 weeks

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

  5. 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)

    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.

  6. Sleep architecture

    Time frame: Baseline, 4 weeks and 8 weeks

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Marrow Donor Program
  • University of Arkansas

Registry information

Acronym: DT2

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2020
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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