Biomarkers for Peripheral Circadian Clocks in Humans

NCT06296823 | Recruiting DMC

• 1 other identifier: 22-0466
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• PYY

  Appetitive hormone-promotes satiety

  hourly for up to 25 hours on two occasions

• Ghrelin

  Appetitive hormone-promotes food intake

  hourly for up to 25 hours on two occasions

• Leptin

  Appetitive hormone-promotes satiety

  hourly for up to 25 hours on two occasions

• CRP

  Acute phase response/also marker of inflammation

  hourly for up to 25 hours on two occasions

• OMD

  Biomineralization

  hourly for up to 25 hours on two occasions

• PAI-1

  Inhibitor of fibrinolysis

  hourly for up to 25 hours on two occasions

• IgE

  Immune responses to parasites and allergens

  hourly for up to 25 hours on two occasions

• CCL18

  Chemotaxis / immune cell trafficking

  hourly for up to 25 hours on two occasions

• PTH

  Serum calcium homeostasis

  hourly for up to 25 hours on two occasions

Secondary Outcomes (3)

• Glucose

  continuously for up to 35 hours on two occasions

• Insulin

  hourly for up to 25 hours on two occasions

• Proteomics

  hourly for up to 25 hours on two occasions

Other Outcomes (9)

• Melatonin

  hourly for up to 25 hours on two occasions

• Cortisol

  hourly for up to 25 hours on two occasions

• Core body temperature

  continuously for up to 35 hours on two occasions

Study Arms (2)

Meal timing

EXPERIMENTAL

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

Behavioral: Simulated jetlag protocol

Bright light

EXPERIMENTAL

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.

Behavioral: Simulated jetlag protocol

Interventions

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.

Bright light; Meal timing

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Sleep and Chronobiology Laboratory

Boulder, Colorado, 80303, United States

RECRUITING

Central Study Contacts

Kenneth Wright, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication, microbiome data to be deposited permanently in International Nucleotide Sequence Database Collaboration www.insdc.org/ Data deposited in Qiita http://qiita.microbio.me Upon publication, proteomics and metabolomics data to be deposited and made freely available (e.g., https://figshare.com, http://gnps.ucsd.edu)
• Access Criteria: microbiome, proteomics and metabolomics data will be freely available at www.insdc.org/, https://figshare.com, and http://gnps.ucsd.edu

Locations

US (1)