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Recruiting NCT06891352

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

Trial Parameters

Condition Night Shift Work
Sponsor Salk Institute for Biological Studies
Study Type INTERVENTIONAL
Phase N/A
Enrollment 180
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-06-02
Completion 2028-08-31
Interventions
Dietary MonitoringTime-Restricted Eating (TRE)Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS)

Brief 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.

Eligibility Criteria

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

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