Time-restricted Eating and Circadian Health in Night Shift Workers (NCT07451132) | Clinical Trial Compass
CompletedNot Applicable
Time-restricted Eating and Circadian Health in Night Shift Workers
Chile22 participantsStarted 2023-10-30
Plain-language summary
The goal of this clinical trial is to learn about the effect of time-restricted eating (TRE) to 10 hours per day on glucose homeostasis, markers of the circadian system, homeostatic and hedonic regulation of appetite, and inflammation/oxidative stress status in night shift workers. The main questions it aims to answer are: 1) How does a time-restricted eating protocol affect glucose homeostasis in shift workers? and 2) How does a time-restricted eating protocol affect markers of the circadian system, homeostatic and hedonic regulation of appetite, and inflammation/oxidative stress status in shift workers? Participants will be asked to follow a TRE protocol on which they must restrict their eating to a self-selected time window of 10 hours a day, with mandatory fasting time between 24:00-06:00h. for 8 weeks. Researchers will compare the intervention with an additional period of 8 weeks, in which the participants will follow their usual diet without any time restriction, to see if the intervention improves glucose regulation appetite and markers of circadian system, homeostatic and hedonic regulation of appetite, and inflammation/oxidative stress.
Who can participate
Age range
18 Years – 60 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:
Adults (range 18 - 60 yrs.) Men and women Performing as a healthcare worker Being a shift-worker for at least 6 months in the current schedule Working in rotating shiftwork, including at least one night shift Reporting no work-related performance difficulties
Exclusion Criteria:
* Current and chronic neurological disorders
* Pathologies related to abnormal adrenal activity
* Liver or kidney disease
* Uncontrolled hypertension, dyslipidemia, and thyroid disease
* Insulin resistance and T2D
* BMI ≥40 kg/m2
* Use of medications known to alter body composition, such as insulin sensitizers, glucocorticoids, or anti-depressants
* Autoimmune diseases with acute symptoms; recent surgery of any kind (in the last 3 months);
* Acute, chronic inflammation (usCRP \>10 mg/L)
* Following any dietary restriction (special diet) in the previous three months
* Having a short sleep (habitual sleep duration of less than 6h per day)
* History of bariatric surgery
* Depression (Beck Depression Inventory) or sleep disorders (Pittsburgh Sleep Questionnaire)
* Night-eating syndrome (Night Eating Questionnaire)
* Intense exercise level (\>3 days/week of high-intensity exercise)
* Having traveled across time zones (at any time during the last month) and planning travel during the study
* Pregnant or intend to become pregnant, and
* Lactating women
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
Change from Baseline in the mean fasting glycemia at 8 weeks
Timeframe: From baseline to the end of treatment (at 8 weeks), in each study period (TRE and REG)