Healthy YoungNCT04086589
Restoring Molecular Circadian Rhythm
An observational study of Healthy Young and Healthy Elderly, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal is to address the mechanisms that account for alteration of circadian rhythms with age. As the blood of aged individuals can produce this alteration, the investigators propose to use such blood samples to "age" circadian rhythms in cultured cells. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young, Healthy Elderly
- What is being tested?
- Observational study without intervention
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to Nov 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparent healthy volunteers
Who may be able to join
- General good health with the following conditions permissible
- cardiovascular risk prevention, intake of low dose aspirin,
- hypertension, intake of beta-blockers, ACE inhibitors, diuretics, calcium channel blockers
- hypercholesterinemia, intake of statins
- Cases: 70-85 years of age
- Controls: 20-35 years of age
Show all 9Show fewer
- Patients must be able to read and understand English
- Participants must sign the informed consent form
- Participants must have a wrist-actigraphy-based average TST (total sleep time) ≥ 6 hours per night (measured over 7 consecutive days) occurring between 22:00 - 08:00
Who cannot join
- Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation
- Shift work, defined as recurring work between 22:00-05:00
- History of clinically significant obstructive sleep apnea
- Transmeridian travel across ≥2 time zones in the two weeks prior to the blood draws and one week after,
- > 2 drinks of alcohol per day
- Use of illicit drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Exploratory Pilot Study to Discover Genes That Restore the Molecular Circadian Rhythm
The goal is to address the mechanisms that account for alteration of circadian rhythms with age. As the blood of aged individuals can produce this alteration, the investigators propose to use such blood samples to "age" circadian rhythms in cultured cells. The investigators will verify aged blood-dependent alteration of rhythms and then conduct molecular screens to reverse this decline. If the investigators identify specific genes that can restore molecular circadian rhythm in vitro, the investigators will explore these in animal models (Drosophila, mouse).
- Conditions
- Healthy Young, Healthy Elderly
- Being tested
- Observational study without intervention
- Keywords
- healthy, young, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study without interventionOther
Observational study without intervention
| Study group | Role | What they receive |
|---|---|---|
| Young | Observational study without intervention Receives: Other: Observational study without intervention | |
| Elderly | Observational study without intervention Receives: Other: Observational study without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta of period length measured in hh:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)
To determine if serum collected from young versus old healthy study participants have a differential effect on the expression of circadian rhythms in an in vitro culture of a fibroblast cell line
Measured: Time point 14:00 Hours
Delta of phase measured in HH:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)
The primary endpoint will be the difference in phase angle in vitro between cycling fibroblasts and incubated with serum collected from cases (old adults) versus controls (young adults)
Measured: Time point 14:00 Hours
Secondary outcomes (8)
Chronotype
Assessed per survey; chronotypes per Munich Chronotype questionnaire are extreme early type, moderate early type, slight early type, normal type, slight late type, moderate late type, extreme late type
Measured: 4 weeks
Acrophase
Clock hour of peak physical activity averaged from 7 or more days of actigraphy
Measured: 7 days
Physical activity
Vector magnitude of physical activity averaged from 7 or more days of actigraphy
Measured: 7 days
Sleep quantity
Hours of sleep averaged from 7 or more days of actigraphy
Measured: 7 or more days
Sleep quality: actigraphy
Sleep fragmentation averaged from 7 or more days of actigraphy
Measured: 7 days
Ambient light exposure
Ambient light exposure averaged from 7 or more days of actigraphy
Measured: 7 days
Heart rate variability
Heart rate variability (RR intervals) averaged from 24 hours of BioPatch
Measured: 24 hours
Saliva cortisol
Difference in concentrations of cortisol measured in saliva between morning versus evening
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start19 Aug 2019
- Primary completionJan 2028 (estimated)
- Study completionNov 2028 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy YoungStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carsten Skarke, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086589
- Sponsor's protocol ID
- 832866
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2019
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Pilot Study to Discover Genes That Restore the Molecular Circadian Rhythm
- ClinicalTrials.gov ID
- NCT04086589
- Acronym / sponsor ID
- 832866
- Conditions
- Healthy Young, Healthy Elderly
- Keywords
- healthy, young, elderly
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 11 Sep 2019 (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 goal is to address the mechanisms that account for alteration of circadian rhythms with age. As the blood of aged individuals can produce this alteration, the investigators propose to use such blood samples to "age" circadian rhythms in cultured cells. The investigators will verify aged blood-dependent alteration of rhythms and then conduct molecular screens to reverse this decline. If the investigators identify specific genes that can restore molecular circadian rhythm in vitro, the investigators will explore these in animal models (Drosophila, mouse).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | – | Other: Observational study without interventionObservational study without intervention |
| Elderly | – | Other: Observational study without interventionObservational study without intervention |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparent healthy volunteers
Key inclusion criteria (9 listed)
- General good health with the following conditions permissible
- Cases: 70-85 years of age
- Controls: 20-35 years of age
- Patients must be able to read and understand English
- Participants must sign the informed consent form
Key exclusion criteria (6 listed)
- Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation
- Shift work, defined as recurring work between 22:00-05:00
- History of clinically significant obstructive sleep apnea
- Transmeridian travel across ≥2 time zones in the two weeks prior to the blood draws and one week after,
- > 2 drinks of alcohol per day
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 |
|---|---|---|
| Observational study without interventionObservational study without intervention | Other | Elderly, Young |
Primary outcome
Delta of period length measured in hh:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)
Time frame: Time point 14:00 Hours
To determine if serum collected from young versus old healthy study participants have a differential effect on the expression of circadian rhythms in an in vitro culture of a fibroblast cell line
Delta of phase measured in HH:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults)
Time frame: Time point 14:00 Hours
The primary endpoint will be the difference in phase angle in vitro between cycling fibroblasts and incubated with serum collected from cases (old adults) versus controls (young adults)
8 secondary outcomes
Chronotype
Time frame: 4 weeks
Acrophase
Time frame: 7 days
Physical activity
Time frame: 7 days
Sleep quantity
Time frame: 7 or more days
Sleep quality: actigraphy
Time frame: 7 days
Ambient light exposure
Time frame: 7 days
Heart rate variability
Time frame: 24 hours
Saliva cortisol
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Carsten 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?
An observational study of Healthy Young and Healthy Elderly, 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 9 inclusion and 6 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: paused, as of the sponsor's last update on 23 Jan 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?
Results are not available in the source record.
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?
Delta of period length measured in hh:mm between in vitro cycling fibroblasts incubated with serum collected from cases (elderly adults) versus controls (young adults) (time frame: Time point 14:00 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.