HealthyNCT04225442
The Physiological Chronobiome Modified by Age, Sex and Under Evoked Conditions
A study testing Fatty meal to challenge the physiological chronobiome in healthy young and old in people with Healthy and Healthy Aging, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Aging
- What is being tested?
- Fatty meal to challenge the physiological chronobiome in healthy young and old
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2020to 4 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young: 18-30 years of age, Old: 55-75 years of age
- Apparent healthy
- BMI (body mass index) up to 27.4
- Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ambulatory blood pressure (ABP) measurements,
- Own and use a smartphone.
Who cannot join
- History of severe psychiatric illness or cognitive conditions, for example (mania, schizophrenia, or mental retardation;
- Shift work, defined as recurring work between 22:00-05:00;
- A diagnosis of clinically significant obstructive sleep apnea;
- Serum creatinine > 1.5 mg/dl in men or >1.3 mg/del in women;
- Significant liver disease (>3x upper limit of normal);
- Diabetes mellitus;
Show all 18Show fewer
- Past diagnosis of gastroesophageal reflux disease,
- Transmeridian travel across ≥3 time zones in the two weeks before the 48hr deep phenotype sessions;
- Use of oral or intravenous antibiotics in the 6 months prior to enrollment;
- Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
- > 2 drinks of alcohol per day;
- Use of drugs assessed in the urinary drug test;
- Nursing or pregnant (pregnancy will be repeatedly assessed at the beginning of each of the four inpatient visits, i.e. prior to the start of blood draws);
- Use of pacemaker or implantable Cardioverter Defibrillator (ICD);
- Bilateral mastectomy;
- History of Raynaud's phenomenon;
- Known allergy against natural latex rubber (contained in ABP bladder and tubing);
- Subjects taking medication with alpha-blockers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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
- Healthy, Healthy Aging
- Being tested
- Fatty meal to challenge the physiological chronobiome in healthy young and old
- Keywords
- Chronobiome, Multiomics, Molecular networks, Circadian clocks, Remote sensing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty meal to challenge the physiological chronobiome in healthy young and oldOther
The intervention consists of a fatty meal
| Study group | Role | What they receive |
|---|---|---|
| Fatty meal | Other | To study how a fatty meal modifies the physiological chronobiome in young and old, an isocaloric controlled liquid high fat meal (ICLHFM) will be consumed within 5 min. The ICLHFM contains an equivalent to 35% of the estimated total daily energy requirements (TDE), 60% of kcal delivered from fat while 13% come from protein and 27 % from carbohydrate. Receives: Other: Fatty meal to challenge the physiological chronobiome in healthy young and old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent difference in the number of proteins with post-translational modifications found in blood samples from young versus old participants
High-throughput proteomics analysis determines the number of proteins with and without post-translational modifications. This will explore what effect age has on the number of proteins with post-translational modifications.
Measured: 48 hours
Secondary outcomes (8)
Percent difference in the number of proteins with post-translational modifications found in blood samples from female versus male participants
High-throughput proteomics analysis determines the number of proteins with and without post-translational modifications. This will explore what effect sex has on the number of proteins with post-translational modifications.
Measured: 48 hours
Percent difference in the number of proteins with post-translational modifications found in blood samples from female versus male participants and by age
High-throughput proteomics analysis determines the number of proteins with and without post-translational modifications. This will explore whether an interaction between age and sex has an effect on the number of proteins with post-translational modifications.
Measured: 48 hours
Percent difference in environmental light exposure between young versus old participants
Wrist actigraphy collects personal light exposure
Measured: 48 hours
Percent difference in environmental light exposure between young versus old participants and by sex
Wrist actigraphy collects personal light exposure
Measured: 48 hours
Percent difference in physical activity between young versus old participants
Wrist actigraphy records accelerometer data to calculate physical activity
Measured: 48 hours
Percent difference in physical activity between young versus old participants and by sex
Wrist actigraphy records accelerometer data to calculate physical activity
Measured: 48 hours
Percent difference in systolic blood pressure readings between young versus old participants
Ambulatory blood pressure measurements (ABPM) collect blood pressure readings
Measured: 48 hours
Percent difference in systolic blood pressure readings between young versus old participants and by sex
Ambulatory blood pressure measurements (ABPM) collect blood pressure readings
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start5 Jan 2020
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Skarke, MD, University of Pennsylvania
- Investigators
- Garret A FitzGerald, MD, Principal investigator, University of PennsylvaniaCarsten C Skarke, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225442
- Sponsor's protocol ID
- 834156
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2020
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6.
PubMed 29215023
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological Chronobiome Modified by Age, Sex and Under Evoked Conditions
- ClinicalTrials.gov ID
- NCT04225442
- Acronym / sponsor ID
- 834156
- Conditions
- Healthy, Healthy Aging
- Keywords
- Chronobiome, Multiomics, Molecular networks, Circadian clocks, Remote sensing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jun 2028 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatty meal | Other | Other: Fatty meal to challenge the physiological chronobiome in healthy young and oldTo study how a fatty meal modifies the physiological chronobiome in young and old, an isocaloric controlled liquid high fat meal (ICLHFM) will be consumed within 5 min. The ICLHFM contains an equivalent to 35% of the estimated total daily energy requirements (TDE), 60% of kcal delivered from fat while 13% come from protein and 27 % from carbohydrate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Young: 18-30 years of age, Old: 55-75 years of age
- Apparent healthy
- BMI (body mass index) up to 27.4
- Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ambulatory blood pressure (ABP) measurements,
- Own and use a smartphone.
Key exclusion criteria (18 listed)
- History of severe psychiatric illness or cognitive conditions, for example (mania, schizophrenia, or mental retardation;
- Shift work, defined as recurring work between 22:00-05:00;
- A diagnosis of clinically significant obstructive sleep apnea;
- Serum creatinine > 1.5 mg/dl in men or >1.3 mg/del in women;
- Significant liver disease (>3x upper limit of normal);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatty meal to challenge the physiological chronobiome in healthy young and oldThe intervention consists of a fatty meal | Other | Fatty meal |
Primary outcome
Percent difference in the number of proteins with post-translational modifications found in blood samples from young versus old participants
Time frame: 48 hours
High-throughput proteomics analysis determines the number of proteins with and without post-translational modifications. This will explore what effect age has on the number of proteins with post-translational modifications.
8 secondary outcomes
Percent difference in the number of proteins with post-translational modifications found in blood samples from female versus male participants
Time frame: 48 hours
Percent difference in the number of proteins with post-translational modifications found in blood samples from female versus male participants and by age
Time frame: 48 hours
Percent difference in environmental light exposure between young versus old participants
Time frame: 48 hours
Percent difference in environmental light exposure between young versus old participants and by sex
Time frame: 48 hours
Percent difference in physical activity between young versus old participants
Time frame: 48 hours
Percent difference in physical activity between young versus old participants and by sex
Time frame: 48 hours
Percent difference in systolic blood pressure readings between young versus old participants
Time frame: 48 hours
Percent difference in systolic blood pressure readings between young versus old participants and by sex
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 29215023Skarke C, Lahens NF, Rhoades SD, Campbell A, Bittinger K, Bailey A, Hoffmann C, Olson RS, Chen L, Yang G, Price TS, Moore JH, Bushman FD, Greene CS, Grant GR, Weljie AM, FitzGerald GA. A Pilot Characterization of the Human Chronobiome. Sci Rep. 2017 Dec 7;7(1):17141. doi: 10.1038/s41598-017-17362-6.
- Philadelphia InquirerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garret A FitzGerald, MD principal investigator
University of Pennsylvania
Carsten C Skarke, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatty meal to challenge the physiological chronobiome in healthy young and old in people with Healthy and Healthy Aging, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent difference in the number of proteins with post-translational modifications found in blood samples from young versus old participants (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.