Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers

Recruiting now · Not applicable

Conditions studied: Night Shift Work, Time Restricted Eating, Overweight, Obesity

In brief

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.

Key facts

Study ID

NCT06891352

Run by

Salk Institute for Biological Studies

People needed

180

Starts

2025-06-02

Expected to finish

2029-03-03

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of California San Diego Altman Clinical and Translational Research Institute — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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