Biomarkers for Peripheral Circadian Clocks in Humans

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-35
SponsorUniversity of Colorado, Boulder

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Meal timingExperimental treatment 1 intervention
Group B: Bright lightExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PYY

Appetitive hormone-promotes satiety

Time frame
hourly for up to 25 hours on two occasions
2

Ghrelin

Appetitive hormone-promotes food intake

Time frame
hourly for up to 25 hours on two occasions
3

Leptin

Appetitive hormone-promotes satiety

Time frame
hourly for up to 25 hours on two occasions
4

CRP

Acute phase response/also marker of inflammation

Time frame
hourly for up to 25 hours on two occasions

Secondary outcomes

1

Glucose

Blood sugar

Time frame
continuously for up to 35 hours on two occasions
2

Insulin

hormone that helps regulated blood glucose levels

Time frame
hourly for up to 25 hours on two occasions
3

Proteomics

proteins

Time frame
hourly for up to 25 hours on two occasions

Other outcomes

1

Melatonin

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

Time frame
hourly for up to 25 hours on two occasions
2

Cortisol

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

Time frame
hourly for up to 25 hours on two occasions
3

Core body temperature

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

Time frame
continuously for up to 35 hours on two occasions
4

Skin temperature

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

Time frame
continuously for up to 35 hours on two occasions

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Boulder

Lead sponsor

University of Colorado, Denver

Collaborator