Recruiting

Observational Study

Sponsor:

University of Colorado, Boulder

Code:

NCT06296823

Conditions

Circadian Rhythms

Eligibility Criteria

Sex: All

Age: 17 - 35

Healthy Volunteers: Accepted

Interventions

Simulated jetlag protocol

Study Details

Brief summary:

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.

Conditions

Circadian Rhythms

Study ID

NCT06296823

Start date

Sep 1, 2023

Status verified date

Jun, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

1\) 17-35 years old 2) English speaking 3) Healthy 5) Altitude history: Currently residing at Denver altitude or higher

Exclusion Criteria:

1\. Any medical, psychiatric, or sleep disorder.

Study Design

Enrollment

14 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Meal timing

Three days of meals, bedtimes and wake times scheduled to occur 5h earlier.

experimental: Bright light

Three 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.

Interventions

Simulated jetlag protocol

16 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.

Primary outcome measure

  • PYY [ Time Frame: hourly for up to 25 hours on two occasions ]
  • Ghrelin [ Time Frame: hourly for up to 25 hours on two occasions ]
  • Leptin [ Time Frame: hourly for up to 25 hours on two occasions ]
  • CRP [ Time Frame: hourly for up to 25 hours on two occasions ]
  • OMD [ Time Frame: hourly for up to 25 hours on two occasions ]
  • PAI-1 [ Time Frame: hourly for up to 25 hours on two occasions ]
  • IgE [ Time Frame: hourly for up to 25 hours on two occasions ]
  • CCL18 [ Time Frame: hourly for up to 25 hours on two occasions ]
  • PTH [ Time Frame: hourly for up to 25 hours on two occasions ]

Central Contacts and Locations

Central contacts

Kenneth Wright, PhD

303-735-1923sleep.study@colorado.edu

Locations

Sleep and Chronobiology Laboratory

Recruiting

Boulder, Colorado, United States, 80303

Contacts

Kenneth Wright

303-735-1923sleep.study@colorado.edu

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2026-06-17.