Optimizing meal timing to improve health in night shift workers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the health effects of optimizing dietary timing in nurses and nursing assistants who work night shifts and have elevated weight. Participants will be randomly assigned to one of three groups: dietary monitoring, dietary monitoring with a 10-hour daytime eating window, or time-restricted eating with a low-glycemic snack during night shifts. The study aims to determine if these dietary adjustments can reduce weight, improve glucose regulation, and enhance other metabolic and cardiovascular health markers over a 12-month period.

Why it matters

Who can join: the full rules

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 greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest
* Fasting LDL cholesterol greater than 250 mg/dL
* Fasting triglycerides greater than 500g/dL
* Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse in the past 5 years.
* Frequent (more than 4) travel involving a time zone change of more than 3 hours over the 1-year study period
* Prolonged leave from work (a continuous month or longer) during the study
* Active treatment for inflammatory and/or rheumatologic disease
* History of a major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack)
* Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are acceptable)
* History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (hypothyroidism on a stable dose of thyroid replacement therapy is allowed).
* History of adrenal disease in the past 5 years
* History of malignancy undergoing active treatment, except non-melanoma skin cancer, in the past 5 years
* History of an eating disorder in the past 5 years
* History of cirrhosis in the past 5 years
* History of stage 4 or 5 chronic kidney disease or dialysis in the past 5 years
* History of HIV/AIDs
* Currently enrolled in weight-loss or weight-management program
* History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators
* Uncontrolled psychiatric disorder including prior hospitalization

Where it's running

• University of California San Diego Altman Clinical and Translational Research Institute
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Emily Manoogian, Ph.D. — Salk Institute for Biological Studies
• Study coordinator: UCSD Study Coordinator
• Email: research@mycircadianclock.org
• Phone: 858-246-2342

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.