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Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers - The SHIFT Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California San Diego Altman Clinical and Translational Research Institute
RECRUITING
La Jolla
Contact Information
Primary
UCSD Study Coordinator
research@mycircadianclock.org
858-246-2342
Backup
Salk Clinical Researcher
research@mycircadianclock.org
858-453-4100
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2029-03-03
Participants
Target number of participants: 180
Treatments
Active_comparator: Dietary Monitoring
Log all dietary intake and continue habitual eating patterns.
Experimental: Time-Restricted Eating (TRE)
Dietary Monitoring and adherence to a personalized consistent 10-hour time-restricted eating window
Experimental: Time-Restricted Eating with Low-Glycemic Snack (TRE-LGS)
Dietary Monitoring and adherence to a modified personalized consistent 10-hour time-restricted eating window a low-glycemic snack provided by the research team to consume during night shifts.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of San Diego
Leads: Salk Institute for Biological Studies

This content was sourced from clinicaltrials.gov