Countermeasures to Circadian Misalignment
NCT04966351 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-07-24
Summary
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.
Conditions
- Circadian Rhythm Sleep Disorder of Shift Work Type
- Metabolic Disease
- Insulin Sensitivity
Interventions
- BEHAVIORAL
-
Time-restricted feeding
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.
- BEHAVIORAL
-
Circadian Misalignment
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.
Sponsors & Collaborators
-
University of Colorado, Denver
collaborator OTHER -
Salk Institute for Biological Studies
collaborator OTHER -
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
Colorado State University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-07
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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