Sleep and Chronobiology Laboratory
Boulder, Colorado, 80303, United States
Location status: Recruiting
NCT Number: NCT06296823
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.
Interested in participating?
Request Info17 year–35 year
All sexes
Interventional
Not applicable
Boulder, Colorado, 80303, United States
Location status: Recruiting
Visit 1: Participants who meet pre-screen/initial inclusion criteria will be consented at Visit 1, complete additional questionnaires and interviews to assess inclusion/exclusion criteria, and we will collect descriptive data as well as have our clinical psychologist perform a clinical interview.
Visit 2: Participants will undergo medical screening at the Clinical Translational Research Center at the University of Colorado Boulder (UCB-CTRC) to determine health status.
Visits 3 & 6: Participants will be asked to maintain a regular ~8h sleep-wake schedule for two weeks prior to Visits 5 and 8. Participants will wear a wrist activity, skin temperature, and light exposure recorder. Participants will be asked to remain in the local time zone during ambulatory recording procedures and be asked to keep their typical schedules (e.g., not stay up all night for work or social events and not reside in a new place different from their place of residence).
Visit 4 & 7: Participants will come to the laboratory on days 11 and 39, where qualified staff will apply a Continuous Glucose Monitoring (CGM) sensor to be worn for ~3 days at home and will continue in the laboratory. For the three days leading up to the study isocaloric meals including breakfast, lunch, and dinner will be provided. Participants will be asked to consume these energy balanced research diets (no caffeine) and meal timing will be scheduled (breakfast ~30 min, lunch ~5h, and dinner ~10h after awakening,). Exercise will be proscribed for these 3-days prior to the in-lab study.
Visits 5 & 8: Participants will be randomized to condition order using an ABBA design (i.e., randomized into one of the two experimental conditions first in a crossover design: 3-days bright light exposure or 3-days of earlier timed meals). Both conditions are tested under an advanced sleep-wake schedule equivalent to traveling 5 time zones east. All participants will complete both conditions. On the second visit, participants will be tested in the other condition. Participants will live in the laboratory for 7.7 days each visit.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: hourly for up to 25 hours on two occasions
Appetitive hormone-promotes satiety
Time frame: hourly for up to 25 hours on two occasions
Appetitive hormone-promotes food intake
Time frame: hourly for up to 25 hours on two occasions
Appetitive hormone-promotes satiety
Time frame: hourly for up to 25 hours on two occasions
Acute phase response/also marker of inflammation
Time frame: hourly for up to 25 hours on two occasions
Biomineralization
Time frame: hourly for up to 25 hours on two occasions
Inhibitor of fibrinolysis
Time frame: hourly for up to 25 hours on two occasions
Immune responses to parasites and allergens
Time frame: hourly for up to 25 hours on two occasions
Chemotaxis / immune cell trafficking
Time frame: hourly for up to 25 hours on two occasions
Serum calcium homeostasis
Time frame: continuously for up to 35 hours on two occasions
Blood sugar
Time frame: hourly for up to 25 hours on two occasions
hormone that helps regulated blood glucose levels
Time frame: hourly for up to 25 hours on two occasions
proteins
Time frame: hourly for up to 25 hours on two occasions
Primary marker of the SCN master clock - high levels represent biological night
Time frame: hourly for up to 25 hours on two occasions
Secondary marker of the SCN master clock - rising/high levels represent biological night
Time frame: continuously for up to 35 hours on two occasions
Secondary marker of the SCN master clock - low levels represent biological night
Time frame: continuously for up to 35 hours on two occasions
Secondary marker of the SCN master clock - high levels represent biological night
Time frame: hourly for up to 35 hours on two occasions
Measures of performance
Time frame: hourly for up to 35 hours on two occasions
systolic and diastolic pressures
Time frame: hourly for up to 25 hours on two occasions
small molecules in the plasma
Time frame: hourly for up to 25 hours on two occasions
oral bacteria
Time frame: hourly for up to 25 hours on two occasions
skin bacteria
Contact information is provided by the study sponsor or research team.
University of Colorado, Boulder
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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