Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05745441

Conditions

PreDiabetes

Obesity

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Early Dinner

Late Dinner

Early Dinner tracer

Late Dinner tracer

Study Details

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.

Conditions

PreDiabetes

Obesity

Healthy

Study ID

NCT05745441

Start date

Jul 5, 2023

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Early Dinner

Dinner before DLMO

Late Dinner

Dinner after DLMO

Early Dinner tracer

Stable isotope of oral \[2H31\] palmitate to measure fat oxidation, given with dinner before DLMO

Late Dinner tracer

Stable isotope of oral \[2H31\] palmitate to measure fat oxidation, given with dinner after DLMO

Primary outcome measure

  • 24-hour total fat oxidation [ Time Frame: baseline, 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Principal Investigator:

Jonathan Jun, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • circadian
  • sleep
  • glucose
  • metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-13.