Dinner Time 2: Effect of Delayed Eating or Sleeping on Metabolism
DT2
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Jan 2021
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2025
CompletedFebruary 4, 2026
February 1, 2026
4.4 years
December 11, 2020
February 2, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline, 4 weeks and 8 weeks
Secondary Outcomes (6)
Change in Free Fatty Acids (FFA, mmol/L)
Baseline, 4 weeks and 8 weeks
Change in Insulin (mcU/ml)
Baseline, 4 weeks and 8 weeks
Change in Triglycerides (mg/dl)
Baseline, 4 weeks and 8 weeks
Change in Oxidation of palmitate (percent of isotope enrichment)
Baseline, 4 weeks and 8 weeks
Change in melatonin [Dim light melatonin onset (DLMO)]
At 2 weeks prior to baseline (samples drawn every 30 minutes, up to 7 hours)
- +1 more secondary outcomes
Study Arms (3)
Early Dinner first
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Dinner at DLMO-3, sleep at DLMO+2
Dinner at DLMO+1, sleep at DLMO+2
Dinner at DLMO+1, sleep at DLMO+6
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- University of Arkansascollaborator
- National Marrow Donor Programcollaborator
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Related Publications (1)
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.
PMID: 32525525BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Jun, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2020
First Posted
December 17, 2020
Study Start
January 15, 2021
Primary Completion
June 19, 2025
Study Completion
June 19, 2025
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will be provided upon request within 1 year after publication and will be available to indefinitely.
- Access Criteria
- The PI will accept requests from other researchers who are examining pertinent outcomes.
We will provide raw data (without identifying information) to journals or other researchers upon request.