DT2: Dinner Time 2: Effect of Delayed Eating or Sleeping on Metabolism

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04671797
Collaborator
University of Arkansas (Other)
66
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3
52.5
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Early dinner
  • Behavioral: Late Dinner
  • Behavioral: Late Dinner + Late Sleep
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Dinner Time 2: Effect of Delayed Eating or Sleeping on Metabolism
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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
Dinner at DLMO-3, sleep at DLMO+2

Behavioral: Late Dinner
Dinner at DLMO+1, sleep at DLMO+2

Behavioral: Late Dinner + Late Sleep
Dinner at DLMO+1, sleep at DLMO+6

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
Dinner at DLMO-3, sleep at DLMO+2

Behavioral: Late Dinner
Dinner at DLMO+1, sleep at DLMO+2

Behavioral: Late Dinner + Late Sleep
Dinner at DLMO+1, sleep at DLMO+6

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
Dinner at DLMO-3, sleep at DLMO+2

Behavioral: Late Dinner
Dinner at DLMO+1, sleep at DLMO+2

Behavioral: Late Dinner + Late Sleep
Dinner at DLMO+1, sleep at DLMO+6

Outcome Measures

Primary Outcome Measures

  1. Change in Free Fatty Acids (FFA, mmol/L) [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 Glucose (mg/dl) [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 Insulin (mcU/ml) [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 Triglycerides (mg/dl) [Baseline, 4 weeks and 8 weeks]

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

  5. Change in Oxidation of palmitate (percent of isotope enrichment) [Baseline, 4 weeks and 8 weeks]

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

  6. Change in melatonin [Dim light melatonin onset (DLMO)] [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224

Sponsors and Collaborators

  • Johns Hopkins University
  • University of Arkansas

Investigators

  • Principal Investigator: Jonathan Jun, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04671797
Other Study ID Numbers:
  • IRB00156120-2
First Posted:
Dec 17, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University

Study Results

No Results Posted as of Mar 2, 2022