Impact of Dinner Timing on Obesity and Prediabetes

Dinner Time for Obesity and Prediabetes

This study tests whether eating dinner earlier or later can help people with obesity and prediabetes improve their metabolism and health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT05745441 on ClinicalTrials.gov

What this trial studies

This study investigates how the timing of dinner affects metabolic health in individuals with obesity and prediabetes compared to healthy individuals. Participants will undergo a detailed assessment of their circadian rhythms and then be randomly assigned to eat dinner either early or late relative to their biological night. The study will utilize metabolic chambers to measure the effects of these different eating times on metabolism. The goal is to understand how aligning meal timing with the body's natural rhythms can improve metabolic outcomes.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-50 with a normal weight or those with obesity and prediabetes.

Not a fit: Patients with sleep disorders, night shift workers, or those with extreme delayed sleep phase may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new dietary recommendations that optimize meal timing for better metabolic health.

How similar studies have performed: Previous studies have suggested that meal timing can influence metabolic health, indicating potential success for this approach.

Eligibility criteria

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

Where this trial is running

Baltimore, Maryland and 1 other locations

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

Study contacts

• Principal investigator: Jonathan Jun, MD — Johns Hopkins University
• Study coordinator: Athena Mavronis

Conditions: PreDiabetes, Obesity, Healthy, circadian, sleep, glucose, metabolism