Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers (NCT06891352) | Clinical Trial Compass
RecruitingNot Applicable
Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers
United States180 participantsStarted 2025-06-02
Plain-language summary
In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.
Who can participate
Age range
18 Years – 70 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: 18-70 years
* BMI ≥ 25 kg/m2 (or ≥ 23 kg/m2 for Asian adults)
* Own a smartphone (Apple iOS or Android OS)
* Baseline eating window ≥ 14 h/day
* Night shift nurses and nursing assistants who are working a 12-hour night shift at least 3 days/week.
* Have been doing night shift work for at least 3 months.
* Patients on cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive, drugs), are allowed
* If patients have Type 2 Diabetes, they will be included in the study if A1c is less than 9 and they are not on insulin.
Exclusion Criteria:
* Insufficient dietary logging on the mCC app is defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart.
* Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
* Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
* Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
* BMI \> 50 kg/m2
* Change in medications that could impact study outcomes within the past 3 months
* Change in weight of \>4kg in the past 3 months
* Women who are pregnant, breastfeeding, or are trying to become pregnant during the study period. If a participant becomes pregnant during the study, they will be excluded from continuing the study.
* Systolic BP greate…
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.