Circadian Misalignment and Energy Balance (NCT03663530) | Clinical Trial Compass
RecruitingNot Applicable
Circadian Misalignment and Energy Balance
United States42 participantsStarted 2019-01-01
Plain-language summary
Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.
Who can participate
Age range
20 Years – 49 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:
* All racial and ethnic groups
* Body mass index 20-34.9 kg/m2
* Average sleep duration ≥7 hour/night, assessed during 2-week screening period
* Eat within 1 hour of awakening at least 5 days/week
* Midpoint of sleep at 4 AM or earlier
Exclusion Criteria:
* \<10 nights of sleep \<7 hour during the 2-week screening period
* Daytime napping
* Current or past sleep disorder (Sleep Disorders Inventory); Insomnia Severity Index Score \>10
* Current or past psychiatric disorder, including eating disorders and seasonal affective disorder
* Any psychological or psychiatric disorder deemed to interfere with study outcomes
* Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers \<3 years)
* Night and rotating shift work
* Travel across time zones within 4 wk of the study
* History of drug or alcohol abuse or excessive alcohol consumption (\>3 drinks/day for men or 2 for women)
* Recent weight change (\>5% gain or loss of body weight over past 3 months) or active participation in diet or weight loss program in previous 3 months; any weight loss procedure
* Pregnancy or \<1 year post-partum
* Diagnosed sleep apnea or high-risk score on Berlin questionnaire (2 or more categories with positive score)
* Depression (score \>13 on Beck Depression Inventory II) or taking anti-depressive medications
* Restless leg syndrome and circadian rhythm disorders
* Dementia or cognitive impairments
* Taking psychoactive or hypnot…
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.