Dinner Time for Obesity and Prediabetes

Recruiting now · Not applicable

Conditions studied: PreDiabetes, Obesity, Healthy

In brief

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.

Key facts

Study ID

NCT05745441

Run by

Johns Hopkins University

People needed

32

Starts

2023-07-05

Expected to finish

2028-03-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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
• 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)

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (enrolling)
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.