Biomarkers for Peripheral Circadian Clocks in Humans
Part of paid clinical trials in Boulder, Colorado.
- Sponsor
- University of Colorado, Boulder
- Study ID
- NCT06296823
- Status
- Recruiting
Conditions
- Circadian Rhythms
Eligibility Criteria
- Sex
- ALL
- Age
- 17 Years - 35 Years
- Healthy Volunteers
- Accepted
Interventions
- Simulated jetlag protocol — BEHAVIORAL16 hours of wakefulness and an 8 hour scheduled sleep opportunity in a simulated jetlag protocol where you will go to bed and awaken earlier than usual.
Study Details
The purpose of this project is to improve our understanding of peripheral circadian rhythms in humans. Circadian clocks are present in most tissues of the body with importance for optimal physiological function, health, and behavior. This project will utilize simulated jetlag protocols to systematically test novel hypotheses about the regulation of peripheral circadian rhythms in humans. Specifically, we will examine how changes in the time of when we are exposed to light and the timing of when we eat impacts proteins in the blood and saliva that represent rhythms from clocks in the brain (e.g., rhythms of the hormones melatonin and cortisol coordinated by the brain) and rhythms from clocks in body tissues (e.g., proteins made by immune and bone cells, and cells in the stomach and liver). We also aim to discover new blood-based biomarkers of peripheral rhythms in humans. We anticipate our findings will be the first step in developing novel circadian based treatments for aligning peripheral clocks under conditions such as jetlag, and for developing novel circadian biomarkers that will advance our scientific understanding of circadian rhythms.
Key Dates
- Start date
- Sep 1, 2023
- Status verified
- Feb 2024
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 14 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Meal timingThree days of meals, bedtimes and wake times scheduled to occur 5h earlier.
- Experimental: Bright lightThree days of exposure to bright light of \~3,000 lux, which is less than one-third the brightness of a sunrise or sunset (timed to start earlier by 1h each day) with scheduled bed and wake times timed 5h earlier.
Primary Outcome Measure
PYY [ Time Frame: hourly for up to 25 hours on two occasions ]
Central Contacts
- Kenneth Wright, PhD303-735-1923
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sleep and Chronobiology Laboratory | Boulder | Colorado | 80303 |
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