No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
32 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for healthy adults and those with obesity or prediabetes to participate in a study about the timing of meals. Participants will learn about how meal timing affects metabolism and health.
I am a healthy adult aged 18-50 with a BMI between 18-24.9.
I am an adult aged 18-50 with obesity and prediabetes.
I can understand and follow study procedures.
I am fully mobile.
You may not be able to join if
I have a sleep disorder like insomnia or sleep apnea.
I work night shifts.
I go to bed after 1:00 AM regularly.
I have gastroesophageal reflux disease affecting me at dinner.
I am a smoker.
I use drugs or alcohol that might interfere with the study.
I have diabetes or take medications for diabetes other than metformin.
I have any metabolic or cardiovascular disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 intak…
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.
Trial Locations
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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) …
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
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