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Active Not RecruitingNCT04225442

The Physiological Chronobiome Modified by Age, Sex and Under Evoked Conditions

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

The investigators piloted the characterization of the human chronobiome. Now, this line of research is extended to explore physiological chronobiome modulated by sex, age and under evoked conditions.

Detailed description

"Is your body clock important? Absolutely. Just ask any morning lark who lives with a night owl, or vice versa". This quote from a piece published in the Philadelphia Inquirer about the investigator's work illustrates the importance of time in one's personal preferences \[https://www.inquirer.com/health/chronobiome-body-clock-university-pennsylvania-20190307.html\]. Several decades of research have found out that how well a person functions, very much depends on how much this person is in harmony with her/his own preferences and environment. This harmony is acutely disturbed when one travels quickly across several time zones, because suddenly the body's physiology is still following the departure time but the arrival time tells the body something different. As a result, travelers often experience sleep problems and indigestion, which usually disappear after a couple of days. This is different in long-term shift workers for whom work outside of the typical daylight hours means that they have a higher risk for diseases including cardiovascular diseases, diabetes and cancer. Another observation has been that many diseases occur or worsen at a specific time of day. Heart attacks, for example, most often occur when patients wake up in the morning. Shortness of breath peaks at 4 am in the morning for patients with asthma. Intriguingly, more and more studies suggest that time of day matters how effective drugs work and how many side effects one might experience. To study this the investigators started to describe the human chronobiome, which foremost looks at time of day differences of a person's physiology, for example, in the small pilot study the investigators saw a difference in break down products, or metabolites, between mornings and evenings. Now, in this present study, the investigators wish to extend the understanding how the human chronobiome differs between healthy men and women, healthy young and old and how it reacts to a fatty meal challenge. This knowledge will help the investigators to say when a finding can still be considered normal or maybe indicates a first sign of disease. The novelty of this approach is that the investigators measure long enough to understand the role of time of day for a person's chronobiome, that the investigators measure many things to obtain a comprehensive representation of a person's chronobiome, that every measure is timestamped, and that the investigators ask participants to eat fatty meals to see how the chronobiome changes.

Conditions

Interventions

TypeNameDescription
OTHERFatty meal to challenge the physiological chronobiome in healthy young and oldThe intervention consists of a fatty meal

Timeline

Start date
2020-01-05
Primary completion
2027-01-04
Completion
2028-06-04
First posted
2020-01-13
Last updated
2026-02-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04225442. Inclusion in this directory is not an endorsement.