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NCT05745441Recruiting

Dinner Time for Obesity and Prediabetes

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
32 (estimated)
First submitted
8 Feb 2023
Start date
5 Jul 2023
Primary completion date
31 Mar 2028
Lead sponsor
Johns Hopkins University
Diseases
Obesity
NCT number
NCT05745441

What you commit to

  • Study type: Interventional
  • Planned participants: 32
  • From 5 Jul 2023 to the primary completion date, 31 Mar 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Pregnant or lactating female (pregnancy test will be required prior to metabolic visits)
  • 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.
  • Use of medications that can affect circadian rhythm (beta blockers, melatonin)
  • Prior bariatric surgery

Other illness

  • Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy
  • Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime
  • 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)
  • Self-reported kidney disease
  • Any known history of an inherited metabolic disorder
  • 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)
  • Presence of a cardiac pacemaker or other implanted electro-medical devices
  • Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
  • History of significant intravenous access issues
  • Other conditions or situations at the discretion of the PI

Lab values

  • Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort
  • Hemoglobin \< 10 g/dL

Other

  • 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
  • Active smoking
  • 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
  • Weight less than 40 kg or more than 180 kg
  • Chronic use of sedative hypnotics, anxiolytics, opiates
  • 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
  • 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.

Who the study is looking for

  • 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.

Criteria the registry did not label

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

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins Bayview Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
National Institutes of Health Clinical Center
Coordinator of this site? Confirm its status
BethesdaUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.