Countermeasures to Circadian Misalignment

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT04966351
Status
Recruiting
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Conditions

  • Circadian Rhythm Sleep Disorder of Shift Work Type
  • Insulin Sensitivity
  • Metabolic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Time-restricted feeding — BEHAVIORAL
    Each subject will participate in both conditions (CM and CM+TRF)--one in which food is allowed during the nighttime period and one in which food will be restricted to the daytime only. Food intake will be matched across conditions and designed to keep participants weight stable.
  • Circadian Misalignment — BEHAVIORAL
    Healthy lean subjects will undergo circadian misalignment induced using a simulated night shift-work protocol in both conditions of the study. Each condition will last approximately 6 days.

Study Details

Insufficient sleep and circadian misalignment are independent risk factors for the development of obesity and diabetes, yet few strategies exist to counter metabolic impairments when these behaviors are unavoidable. This project will examine whether avoiding food intake during the biological night can mitigate the impact of circadian misalignment on metabolic homeostasis in adults during simulated night shift work. Findings from this study could identify a translatable strategy to minimize metabolic diseases in populations that include anyone working nonstandard hours such as police, paramedics, firefighters, military personnel, pilots, doctors and nurses, truck drivers, and individuals with sleep disorders.

Key Dates

Start date
Jul 7, 2021
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Circadian misalignment (Condition A)
    Participants will eat meals during the biological nighttime while remaining awake to mimic overnight work shifts.
  • Experimental: Circadian misalignment with time-restricted feeding (Condition B)
    Participants will fast during the biological nighttime while remaining awake to mimic overnight work shifts.

Primary Outcome Measure

Insulin sensitivity-derived from glucose tolerance test [ Time Frame: Change to be assessed at Day 3, Day 5, Day 31, Day 33. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Colorado State UniversityFort CollinsColorado80523
Ellen Lyon, M.S.
[email protected]
970-491-3103

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By research site
Colorado State University· Fort Collins, CO

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