Dinner Time for Obesity and Prediabetes (DTOP)

April 9, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, cross-over study that examines the metabolic impact of early vs late dinner, as defined by proximity of food intake to an individual's biological night as determined by dim light melatonin onset (DLMO) in normal-weight, healthy adult volunteers and in adults with obesity and prediabetes. Each participant will first undergo circadian phenotyping at the Johns Hopkins Bayview Clinical Research Unit (Baltimore, Maryland), with assessment of DLMO and core body temperature profile, as well as wrist actigraphy. Thereafter, participants will be crossover randomized to (1) a 24-hour metabolic chamber protocol where dinner is eaten 3 hours before DLMO (early dinner), or (2) a 24-hour metabolic chamber protocol where dinner is 1 hour eaten after DLMO (late dinner), both to be performed at the NIH Metabolic Clinical Research Unit (Bethesda, Maryland). The timing and nutritional contents of all meals, as well as sleep timing and duration, will be held constant. Oral [2H31] palmitate will be given with each dinner condition to quantify dietary fat oxidation. The 2 dinner conditions will occur in random order, with a 3- to 4-week washout period.

The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants. At this time (5/2023) the investigators are focusing on the NWH group.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Bayview Medical Center
        • Contact:
        • Principal Investigator:
          • Jonathan Jun, MD
        • Contact:
        • Sub-Investigator:
          • Daisy Duan, MD
        • Sub-Investigator:
          • Luu Pham, MD
      • Bethesda, Maryland, United States, 20892
        • Not yet recruiting
        • National Institutes of Health Clinical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephanie T Chung, MBBS
        • Sub-Investigator:
          • Kong Y Chen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Participants who have travelled across time zones must have adequate time to recover from jet lag prior to enrollment (i.e., at least 3 days per time zone). Travel across >1 time zone after enrollment in the study will not be permitted.
  • Weight less than 40 kg or more than 180 kg
  • Gastrointestinal disorders that can lead to obstruction of the digestive tract (i.e. diverticular disease, history of bowel obstruction, inflammatory bowel disease, motility disorder)
  • History of any surgical procedures in the gastrointestinal tract.
  • Swallowing disorders
  • Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
  • Chronic use of sedative hypnotics, anxiolytics, opiates
  • Use of medications that can affect circadian rhythm (beta blockers, melatonin)
  • Presence of a cardiac pacemaker or other implanted electro-medical devices
  • Those who have to undergo strong electromagnetic field during the period of use of the ingestible thermosensor (i.e. MRI)
  • Weight loss or gain of ≥ 5% of total body weight over the preceding 3 months
  • Currently participating in a weight loss program
  • Prior bariatric surgery
  • Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
  • History of significant intravenous access issues
  • Non-English speaking individuals: The complexity of the instructions for various components of the study would make the study procedures difficult to follow in the setting of a language barrier.
  • Other conditions or situations at the discretion of the PI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Dinner First
Participants 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.
Behavioral: Early Dinner
Dinner before DLMO
Behavioral: Late Dinner
Dinner after DLMO
Drug: Early Dinner tracer
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner before DLMO
Drug: Late Dinner tracer
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner after DLMO
Experimental: Late Dinner First
Participants 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.
Behavioral: Early Dinner
Dinner before DLMO
Behavioral: Late Dinner
Dinner after DLMO
Drug: Early Dinner tracer
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner before DLMO
Drug: Late Dinner tracer
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner after DLMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour total fat oxidation
Time Frame: baseline, 4 weeks
Within-subject difference in total fat oxidation between early dinner and late dinner conditions.
baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4-hour post-prandial area-under-the-curve (AUC) glucose levels
Time Frame: baseline, 4 weeks
Within-subject difference in post-prandial AUC glucose levels between early dinner and late dinner conditions.
baseline, 4 weeks
4-hour post-prandial area-under-the-curve insulin levels
Time Frame: baseline, 4 weeks
Within-subject difference in post-prandial AUC insulin levels between early dinner and late dinner conditions.
baseline, 4 weeks
14-hour post-dinner cumulative dietary fat oxidation
Time Frame: baseline, 4 weeks
Within-subject difference in dietary fat oxidation between early dinner and late dinner conditions.
baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Stephanie T Chung, MBBS, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Principal Investigator: Jonathan Jun, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00301239
  • K23DK133690 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will provide raw data (without identifying information) to journals or other researchers upon request.

IPD Sharing Time Frame

The data will be provided upon request within 1 year after publication and will be available to indefinitely.

IPD Sharing Access Criteria

The PI will accept requests from other researchers who are examining pertinent outcomes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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