HealthyNCT02249793
Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
An observational study of Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
As citizens of the information age, humans leave digital traces of behavior in their communication and movement patterns through our cell phone. The Global Positioning System (GPS) technology tracks the way persons commute to school or work or when visiting family and friends. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Volunteers must be in good health as based on medical history, physical examination, vital signs, and laboratory tests as deemed by PI;
- Volunteers are capable of giving informed consent;
- 25-35 years of age;
- Own a cell phone with internet access (smartphone with Android operating system only at this point) which installs the social sensing application ginger.io;
- Non-smoking;
- Male subjects only if feasible during recruitment; and
- In case female volunteers are invited to enroll: non-pregnant, female subjects must consent to a urine pregnancy test.
Who cannot join
- Recent travel across time zones (within the past month);
- Planned travel across time zones during the planned study activities;
- Volunteers with irregular work hours, e.g. night shifts.
- Use of illicit drugs;
- 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.
- Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Exploratory Study in Healthy Volunteers to Define Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
As citizens of the information age, humans leave digital traces of behavior in their communication and movement patterns through our cell phone. The Global Positioning System (GPS) technology tracks the way persons commute to school or work or when visiting family and friends. Circadian rhythmicity describes the concept that many of the bodily functions follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best during daytime while humans rest and sleep during nighttime. The current study wishes to look for a relationship between patterns in participants' cell phone use (Android only at this point) and several of their bodily functions.
Read the detailed description
Cell phones with internet access (so-called smartphones) represent a rich source for user activity data. Each time one places a call, sends a text message, or uses an app, a data trace is being produced which overall reflects the user's social activity and behavior. This data is called 'social sensing data'. Researchers connected this type of data to the health status of the person operating the cell phone. An example is that an outbreak of seasonal flu may lead to fewer calls and text messages among cell phone users. Thus, the social sensing data may show for example how severe an outbreak is and how fast it is spreading.
"Circadian rhythmicity" describes the concept that many of the bodily functions follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best during daytime while rest and sleep occurs during nighttime. A disturbance of this pattern, for example by regular nightshift work, may lead to an increased disease risk, such as for the cardiovascular system, the heart and blood vessels. Natural factors within a body produce our 24-hour rhythm. This rhythm is affected by outside cues such as sunlight. Jet lag is a short-term form of a disturbed 24-hour rhythm. When a person travels fast through several time zones, by plane for example from the East to the West Coast of the US, s/he arrives with a time difference of 3 hours. Upon arrival, the body runs still at East Coast time, but is exposed to the environmental cues following the West Coast time, which may make the person feel groggy and disoriented at first. Within a couple of days the body time usually adjusts and the complaints discontinue.
The current study wishes to look for a relationship between patterns in the participant's cell phone use (Android only at this point) and several of the bodily functions. As bodily functions the investigators will measure blood pressure and breakdown products (metabolites) in urine, blood and saliva samples. The investigators will collect stool samples and use swabs to collect the microbes inhabiting the mouth as well as the rectum. The investigators will also measure messenger ribonucleic acid (mRNA), messenger products of the participant's heritable information, in the blood. A cell phone application called "Ginger.io" will collect the participants' cell phone usage information. This application will also ask the participant several questions during the installation, during participation as well as at the end. Furthermore, the investigators will ask the participant about the dietary intake and habits.
The aim is to learn how the 24-hour rhythm is connected to the social activity and behavior as well as blood pressure and metabolites as markers for the health status.
- Conditions
- Healthy
- Keywords
- circadian, oscillation, clock, human, social behavior, cell phone with internet access (so-called smartphone), social sensing, behavioral feature, Ginger.io, blood pressure, metabolism, metabolomics, gut bacteria, microbiome
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calls and Text Messages
Aggregate communication as behavioral features has been collected using the cell phone data streams.
Measured: 3-4 months
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure
Ambulatory blood pressure monitoring
Measured: 48 hours
Percentage of Total Metabolites
Percentage of metabolites displaying different abundances in biosamples collected during the morning hours versus evening hours. Analysis was performed for all participants as a group.
Measured: 48 hours
Mobility Radius
The approximate radius of an imaginary circle encompassing the various locations that a user has traveled across on a particular day (in miles)
Measured: 3-4 months
Calls
Number of phone calls placed and received
Measured: 3-4 months
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure
Ambulatory blood pressure monitoring
Measured: 48 hours
Unanswered Calls
The number of calls unanswered.
Measured: 3-4 months
Unique Contacts
The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity
Measured: 3-4 months
Call Duration
The duration of calls (made + received)
Measured: 3-4 months
Text Message Length
The total length of all sms messages (sent + received) in characters
Measured: 3-4 months
Text Messages
The number of sms messages (sent + received)
Measured: 3-4 months
Secondary outcomes (8)
Self-reported Sleep Times [Survey]
Cell phone administered survey where participants indicated start and end of sleep times. From this the total hours of sleep per night was calculated.
Measured: 3-4 months
Time Asleep
Hours asleep per each 24 hour period measured by actigraphy
Measured: 3-4 months
Physical Activity
Difference in locomotion between wake and sleep times
Measured: 3-4 months
Changes Over Time in Nutrient Intake - Energy
Nutrient intake will be measured using food photography
Measured: 48 hours
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
Measured: 48 hours
Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
Analysis was performed for all participants as a group.
Measured: 48 hours
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours
Analysis was performed for all participants as a group.
Measured: 48 hours
Changes Over Time in Kidney Function
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 posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Ginger.io
- Responsible party
- Principal investigator, Carsten Skarke, MD, University of Pennsylvania
- Investigators
- Carsten Skarke, MD, Principal investigator, University of PennsylvaniaGarret A FitzGerald, MD, Principal investigator, University of PennsylvaniaAalim Weljie, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249793
- Sponsor's protocol ID
- 817759
- Status last verified
- Feb 2026
- First submitted
- 25 Mar 2014
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study in Healthy Volunteers to Define Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
- ClinicalTrials.gov ID
- NCT02249793
- Acronym / sponsor ID
- 817759
- Conditions
- Healthy
- Keywords
- circadian, oscillation, clock, human, social behavior, cell phone with internet access (so-called smartphone), social sensing, behavioral feature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Ginger.io
- Study start
- Sep 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As citizens of the information age, humans leave digital traces of behavior in their communication and movement patterns through our cell phone. The Global Positioning System (GPS) technology tracks the way persons commute to school or work or when visiting family and friends. Circadian rhythmicity describes the concept that many of the bodily functions follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best during daytime while humans rest and sleep during nighttime. The current study wishes to look for a relationship between patterns in participants' cell phone use (Android only at this point) and several of their bodily functions.
Detailed description
Cell phones with internet access (so-called smartphones) represent a rich source for user activity data. Each time one places a call, sends a text message, or uses an app, a data trace is being produced which overall reflects the user's social activity and behavior. This data is called 'social sensing data'. Researchers connected this type of data to the health status of the person operating the cell phone. An example is that an outbreak of seasonal flu may lead to fewer calls and text messages among cell phone users. Thus, the social sensing data may show for example how severe an outbreak is and how fast it is spreading.
"Circadian rhythmicity" describes the concept that many of the bodily functions follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best during daytime while rest and sleep occurs during nighttime. A disturbance of this pattern, for example by regular nightshift work, may lead to an increased disease risk, such as for the cardiovascular system, the heart and blood vessels. Natural factors within a body produce our 24-hour rhythm. This rhythm is affected by outside cues such as sunlight. Jet lag is a short-term form of a disturbed 24-hour rhythm. When a person travels fast through several time zones, by plane for example from the East to the West Coast of the US, s/he arrives with a time difference of 3 hours. Upon arrival, the body runs still at East Coast time, but is exposed to the environmental cues following the West Coast time, which may make the person feel groggy and disoriented at first. Within a couple of days the body time usually adjusts and the complaints discontinue.
The current study wishes to look for a relationship between patterns in the participant's cell phone use (Android only at this point) and several of the bodily functions. As bodily functions the investigators will measure blood pressure and breakdown products (metabolites) in urine, blood and saliva samples. The investigators will collect stool samples and use swabs to collect the microbes inhabiting the mouth as well as the rectum. The investigators will also measure messenger ribonucleic acid (mRNA), messenger products of the participant's heritable information, in the blood. A cell phone application called "Ginger.io" will collect the participants' cell phone usage information. This application will also ask the participant several questions during the installation, during participation as well as at the end. Furthermore, the investigators will ask the participant about the dietary intake and habits.
The aim is to learn how the 24-hour rhythm is connected to the social activity and behavior as well as blood pressure and metabolites as markers for the health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Healthy volunteers |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (7 listed)
- Volunteers must be in good health as based on medical history, physical examination, vital signs, and laboratory tests as deemed by PI;
- Volunteers are capable of giving informed consent;
- 25-35 years of age;
- Own a cell phone with internet access (smartphone with Android operating system only at this point) which installs the social sensing application ginger.io;
- Non-smoking;
Key exclusion criteria (6 listed)
- Recent travel across time zones (within the past month);
- Planned travel across time zones during the planned study activities;
- Volunteers with irregular work hours, e.g. night shifts.
- Use of illicit drugs;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calls and Text Messages
Time frame: 3-4 months
Aggregate communication as behavioral features has been collected using the cell phone data streams.
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure
Time frame: 48 hours
Ambulatory blood pressure monitoring
Percentage of Total Metabolites
Time frame: 48 hours
Percentage of metabolites displaying different abundances in biosamples collected during the morning hours versus evening hours. Analysis was performed for all participants as a group.
Mobility Radius
Time frame: 3-4 months
The approximate radius of an imaginary circle encompassing the various locations that a user has traveled across on a particular day (in miles)
Calls
Time frame: 3-4 months
Number of phone calls placed and received
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure
Time frame: 48 hours
Ambulatory blood pressure monitoring
Unanswered Calls
Time frame: 3-4 months
The number of calls unanswered.
Unique Contacts
Time frame: 3-4 months
The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity
Call Duration
Time frame: 3-4 months
The duration of calls (made + received)
Text Message Length
Time frame: 3-4 months
The total length of all sms messages (sent + received) in characters
Text Messages
Time frame: 3-4 months
The number of sms messages (sent + received)
8 secondary outcomes
Self-reported Sleep Times [Survey]
Time frame: 3-4 months
Time Asleep
Time frame: 3-4 months
Physical Activity
Time frame: 3-4 months
Changes Over Time in Nutrient Intake - Energy
Time frame: 48 hours
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
Time frame: 48 hours
Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
Time frame: 48 hours
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours
Time frame: 48 hours
Changes Over Time in Kidney Function
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Zenodo data repositoryLink provided by the sponsor.
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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
Garret A FitzGerald, MD principal investigator
University of Pennsylvania
Aalim Weljie, PhD 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, 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 7 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: finished, as of the sponsor's last update on 17 Mar 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?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calls and Text Messages (time frame: 3-4 months). The study lists 11 primary outcomes in all. 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 NCT02249793, 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 17 Mar 2026.