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

Part of paid clinical trials in La Jolla, California.

Sponsor
Salk Institute for Biological Studies
Study ID
NCT06891352
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dietary Monitoring — BEHAVIORAL
    Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and continue their habitual eating patterns.
  • Time-Restricted Eating (TRE) — BEHAVIORAL
    Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window.
  • Time-Restricted Eating with a Low-Glycemic Snack (TRE-LGS) — BEHAVIORAL
    Participants in the group will receive standard advice for a healthy lifestyle, log all food and beverage intake on the myCircadianClock app, and adhere to a personalized consistent 10-hour time-restricted eating window. On nights that participants work night shifts, they will consume a low-glycemic snack provided by the research team.

Study Details

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 Dates

Start date
Jun 2, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2028
Completion
Mar 3, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Total Body Fat Mass (kg) [ Time Frame: Baseline, 3 month, 6 month (primary), and 12 month (follow-up) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego Altman Clinical and Translational Research InstituteLa JollaCalifornia92037
UCSD Study Coordinator
[email protected]
858-246-2342
Salk Clinical Researcher
[email protected]
858-453-4100
Pam Taub, MD (SUB_INVESTIGATOR)
Emily Manoogian, PhD (PRINCIPAL_INVESTIGATOR)

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By condition
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EndocrinologyMetabolic healthWeight loss
By research site
University of California San Diego Altman Clinical and Translational Research Institute· La Jolla, CA

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