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NCT Number: NCT06296823

Biomarkers for Peripheral Circadian Clocks in Humans

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.

Recruiting

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Key information

Conditions

Age range

17 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep and Chronobiology Laboratory

Boulder, Colorado, 80303, United States

Location status: Recruiting

Location contact

Kenneth Wright

CONTACT

[email protected]

303-735-1923

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any medical, psychiatric, or sleep disorder.

Treatment and study plan

Simulated jetlag protocol

Behavioral

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 outcomes

  1. PYY

    Time frame: hourly for up to 25 hours on two occasions

    Appetitive hormone-promotes satiety

  2. Ghrelin

    Time frame: hourly for up to 25 hours on two occasions

    Appetitive hormone-promotes food intake

  3. Leptin

    Time frame: hourly for up to 25 hours on two occasions

    Appetitive hormone-promotes satiety

  4. CRP

    Time frame: hourly for up to 25 hours on two occasions

    Acute phase response/also marker of inflammation

  5. OMD

    Time frame: hourly for up to 25 hours on two occasions

    Biomineralization

  6. PAI-1

    Time frame: hourly for up to 25 hours on two occasions

    Inhibitor of fibrinolysis

  7. IgE

    Time frame: hourly for up to 25 hours on two occasions

    Immune responses to parasites and allergens

  8. CCL18

    Time frame: hourly for up to 25 hours on two occasions

    Chemotaxis / immune cell trafficking

  9. PTH

    Time frame: hourly for up to 25 hours on two occasions

    Serum calcium homeostasis

Secondary outcomes

  1. Glucose

    Time frame: continuously for up to 35 hours on two occasions

    Blood sugar

  2. Insulin

    Time frame: hourly for up to 25 hours on two occasions

    hormone that helps regulated blood glucose levels

  3. Proteomics

    Time frame: hourly for up to 25 hours on two occasions

    proteins

Other outcomes

  1. Melatonin

    Time frame: hourly for up to 25 hours on two occasions

    Primary marker of the SCN master clock - high levels represent biological night

  2. Cortisol

    Time frame: hourly for up to 25 hours on two occasions

    Secondary marker of the SCN master clock - rising/high levels represent biological night

  3. Core body temperature

    Time frame: continuously for up to 35 hours on two occasions

    Secondary marker of the SCN master clock - low levels represent biological night

  4. Skin temperature

    Time frame: continuously for up to 35 hours on two occasions

    Secondary marker of the SCN master clock - high levels represent biological night

  5. Cognition

    Time frame: hourly for up to 35 hours on two occasions

    Measures of performance

  6. Blood pressure

    Time frame: hourly for up to 35 hours on two occasions

    systolic and diastolic pressures

  7. Metabolomics (grant application planned to analyze not currently funded)

    Time frame: hourly for up to 25 hours on two occasions

    small molecules in the plasma

  8. Oral microbiome (grant application planned to analyze not currently funded)

    Time frame: hourly for up to 25 hours on two occasions

    oral bacteria

  9. Skin microbiome (grant application planned to analyze not currently funded)

    Time frame: hourly for up to 25 hours on two occasions

    skin bacteria

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth Wright, PhD

CONTACT

[email protected]

303-735-1923

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • University of Colorado, Denver

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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