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Dinner Time for Obesity and Prediabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how meal timing, compared with the body's natural daily clock, affects how the body uses food and energy. It is for adults ages 18–50 who are either healthy and at a normal weight or have obesity and prediabetes (blood sugar above normal but below the diabetes range).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–50 years old.
  • For the healthy group: have a BMI of 18–24.9. BMI is a measure of weight compared with height.
  • For the obesity and prediabetes group: have a BMI of 30 or higher and prediabetes.
  • Be fully able to move around, understand the study steps, and follow them for the whole study.

Who can't join

  • Have certain sleep problems, work night shifts, or have a very late sleep schedule. Time-zone travel must also meet study rules.
  • Have diabetes, kidney disease, heart disease, or another illness that affects how the body uses energy. Certain high blood sugar test results or low hemoglobin (a protein in red blood cells) also rule people out.
  • Have acid reflux that makes late dinners hard to tolerate, trouble swallowing, certain bowel problems, or any past surgery on the digestive tract.
  • Be pregnant, breastfeeding, nearing menopause, or past menopause.
  • Smoke, use drugs or alcohol in a way that could disrupt the study, or take medicines that affect sleep, the body clock, or how the body uses energy. Diabetes medicines other than metformin are not allowed.
  • Weigh below 40 kg or above 180 kg, have gained or lost at least 5% of body weight in 3 months, be in a weight-loss program, or be a college or professional athlete.
  • Have an implanted electronic device, need an MRI or other strong magnetic-field exposure while using the swallowed temperature sensor, or have major trouble getting an IV placed.
  • Have strict diet needs or food allergies, do not speak English, or have another condition or situation the study team decides makes participation unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

MD