Daytime vs. Delayed Eating Among Obese Individuals (NCT03354169) | Clinical Trial Compass
CompletedNot Applicable
Daytime vs. Delayed Eating Among Obese Individuals
United States38 participantsStarted 2018-02-07
Plain-language summary
The randomized, cross-over design study is designed to determine how timing of eating affects weight, adiposity, energy metabolism, and gene expression. Obese participants will be provided isocaloric meals and snacks to be consumed in one of two prescribed eating conditions -- daytime eating and delayed eating.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 21-50
* BMI of 30-50 kg/m2
* stable weight (±10 lb) over the previous 6 months
* women must be pre-menopausal with regular menstrual cycles
Exclusion Criteria:
* unstable, serious medical conditions
* use of medicine linked to weight gain/loss
* cardiac conditions
* cancer
* diabetes
* autoimmune disease
* use of illicit drugs, melatonin, diuretics or hypnotics
* involved in a current weight loss program
* presence of an untreated sleep disorder (determined by surveys and actigraphy)
* those who work shift work
* those with extreme chronotypes
* habitual waking outside of 0600h-0930h
* habitual bedtime \<2200h or \>2400h
* sleep duration of \<6.5 or \>8.5 h/night.
* psychiatric exclusions will be: depression (Patient Health Questionnaire-9 score ≥9), lifetime bipolar disorder, psychosis, or eating disorder; or any other severe psychiatric disorder judged to interfere with study adherence as assessed by the MINI International Neuropsychiatric Interview.
* structured exercise \>3 d/wk, for \>30 min measured by exercise logs and actigraphy; normal activity levels are required during the study (±30 min/wk of baseline level).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body Mass (Weight)
Timeframe: pre-post changes between the daytime and delayed eating conditions (each 8 weeks long)
2
Adiposity - Total Body Fat
Timeframe: pre-post changes between the daytime and delayed eating conditions (8 weeks).
3
Energy Homeostasis Outcomes - REE
Timeframe: pre-post changes between the daytime and delayed eating conditions (8 weeks).
4
Energy Homeostasis - Respiratory Quotient
Timeframe: pre-post changes between the daytime and delayed eating conditions (8 weeks).