protocolSection identificationModule nctId: NCT06296823, orgStudyIdInfo id: 22-0466, briefTitle: Biomarkers for Peripheral Circadian Clocks in Humans, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Boulder, class: OTHER, collaborators name: University of Colorado, Denver, descriptionModule briefSummary: 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., conditionsModule conditions: Circadian Rhythms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Simulated jetlag protocol, outcomesModule primaryOutcomes measure: PYY, primaryOutcomes measure: Ghrelin, primaryOutcomes measure: Leptin, primaryOutcomes measure: CRP, primaryOutcomes measure: OMD, primaryOutcomes measure: PAI-1, primaryOutcomes measure: IgE, primaryOutcomes measure: CCL18, primaryOutcomes measure: PTH, secondaryOutcomes measure: Glucose, secondaryOutcomes measure: Insulin, secondaryOutcomes measure: Proteomics, otherOutcomes measure: Melatonin, otherOutcomes measure: Cortisol, otherOutcomes measure: Core body temperature, otherOutcomes measure: Skin temperature, otherOutcomes measure: Cognition, otherOutcomes measure: Blood pressure, otherOutcomes measure: Metabolomics (grant application planned to analyze not currently funded), otherOutcomes measure: Oral microbiome (grant application planned to analyze not currently funded), otherOutcomes measure: Skin microbiome (grant application planned to analyze not currently funded), eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Sleep and Chronobiology Laboratory, status: RECRUITING, city: Boulder, state: Colorado, zip: 80303, country: United States, contacts name: Kenneth Wright, role: CONTACT, phone: 303-735-1923, email: sleep.study@colorado.edu, geoPoint lat: 40.01499, lon: -105.27055, hasResults: False