Dinner Time for Obesity and Prediabetes
DTOP
2 other identifiers
interventional
32
1 country
2
Brief Summary
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
2 active sites
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
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedStudy Start
First participant enrolled
July 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
April 13, 2026
April 1, 2026
4.7 years
February 8, 2023
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24-hour total fat oxidation
Within-subject difference in total fat oxidation between early dinner and late dinner conditions.
baseline, 4 weeks
Secondary Outcomes (3)
4-hour post-prandial area-under-the-curve (AUC) glucose levels
baseline, 4 weeks
4-hour post-prandial area-under-the-curve insulin levels
baseline, 4 weeks
14-hour post-dinner cumulative dietary fat oxidation
baseline, 4 weeks
Study Arms (2)
Early Dinner First
EXPERIMENTALParticipants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.
Late Dinner First
EXPERIMENTALParticipants will be served dinner and a stable isotope of oral \[2H31\] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.
Interventions
Stable isotope of oral \[2H31\] palmitate to measure fat oxidation, given with dinner before DLMO
Stable isotope of oral \[2H31\] palmitate to measure fat oxidation, given with dinner after DLMO
Eligibility Criteria
You may qualify if:
- For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively
- For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes
- All participants must be able to understand study procedures, to comply with the procedures for the entire length of the study and be fully mobile.
You may not qualify if:
- Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy
- Night shift work
- Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00
- Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime
- Active smoking
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Diabetes (type 1 or 2) or on any diabetes medications besides metformin
- Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease)
- Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort
- Hemoglobin \< 10 g/dL
- Self-reported kidney disease
- Any known history of an inherited metabolic disorder
- Pregnant or lactating female (pregnancy test will be required prior to metabolic visits)
- Peri-menopausal or post-menopausal female as determined by follicle stimulating hormone of \> 30 mIU/mL or fewer than 3 menstrual periods in 6 months
- Professional or collegiate athlete
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (2)
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: 32525525BACKGROUNDDuan D, Gu C, Polotsky VY, Jun JC, Pham LV. Effects of Dinner Timing on Sleep Stage Distribution and EEG Power Spectrum in Healthy Volunteers. Nat Sci Sleep. 2021 May 14;13:601-612. doi: 10.2147/NSS.S301113. eCollection 2021.
PMID: 34017207BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Jun, MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Stephanie T Chung, MBBS
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
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
February 8, 2023
First Posted
February 27, 2023
Study Start
July 5, 2023
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
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.
The investigators will provide raw data (without identifying information) to journals or other researchers upon request.