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Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics

Exploratory Study in Healthy Volunteers to Define Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02249793
Enrollment
6
Registered
2014-09-26
Start date
2014-09-01
Completion date
2017-12-01
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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. 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.

Interventions

None listed

Sponsors

University of Pennsylvania
Lead SponsorOTHER
Ginger.io
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Calls and Text Messages3-4 monthsAggregate communication as behavioral features has been collected using the cell phone data streams.
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure48 hoursAmbulatory blood pressure monitoring
Percentage of Total Metabolites48 hoursPercentage 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 Radius3-4 monthsThe approximate radius of an imaginary circle encompassing the various locations that a user has traveled across on a particular day (in miles)
Calls3-4 monthsNumber of phone calls placed and received
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure48 hoursAmbulatory blood pressure monitoring
Unanswered Calls3-4 monthsThe number of calls unanswered.
Unique Contacts3-4 monthsThe total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity
Call Duration3-4 monthsThe duration of calls (made + received)
Text Message Length3-4 monthsThe total length of all sms messages (sent + received) in characters
Text Messages3-4 monthsThe number of sms messages (sent + received)

Secondary

MeasureTime frameDescription
Self-reported Sleep Times [Survey]3-4 monthsCell phone administered survey where participants indicated start and end of sleep times. From this the total hours of sleep per night was calculated.
Time Asleep3-4 monthsHours asleep per each 24 hour period measured by actigraphy
Physical Activity3-4 monthsDifference in locomotion between wake and sleep times
Changes Over Time in Nutrient Intake - Energy48 hoursNutrient intake will be measured using food photography
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH48 hours
Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome48 hoursAnalysis was performed for all participants as a group.
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours48 hoursAnalysis was performed for all participants as a group.
Changes Over Time in Kidney Function48 hours

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarsten Skarke, MD

University of Pennsylvania

PRINCIPAL_INVESTIGATORGarret A FitzGerald, MD

University of Pennsylvania

PRINCIPAL_INVESTIGATORAalim Weljie, PhD

University of Pennsylvania

Participant flow

Recruitment details

Study Started 9/24/14, Ended 3/11/15 located at the Clinical and Translational Research Center, CTRC located at the University of Pennsylvania Hospital

Participants by arm

ArmCount
Male Healthy Volunteers
Males
6
Total6

Baseline characteristics

CharacteristicMale Healthy Volunteers
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
3 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 6
other
Total, other adverse events
1 / 6
serious
Total, serious adverse events
0 / 6

Outcome results

Primary

Call Duration

The duration of calls (made + received)

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupCall DurationAwake820.4 Seconds
Study GroupCall DurationSleeping22.0 Seconds
Primary

Calls

Number of phone calls placed and received

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupCallsSleeping0.1 Calls
Study GroupCallsAwake2.7 Calls
Primary

Calls and Text Messages

Aggregate communication as behavioral features has been collected using the cell phone data streams.

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupCalls and Text MessagesAwake18.7 Calls and text messages
Study GroupCalls and Text MessagesSleeping0.9 Calls and text messages
Primary

Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure

Ambulatory blood pressure monitoring

Time frame: 48 hours

ArmMeasureGroupValue (MEAN)Dispersion
Study GroupChanges Over Time in Ambulatory Blood Pressure - Diastolic Blood PressureDifference Day versus Night20.7 mmHgStandard Deviation 3.3
Study GroupChanges Over Time in Ambulatory Blood Pressure - Diastolic Blood PressureAwake78.5 mmHgStandard Deviation 9.1
Study GroupChanges Over Time in Ambulatory Blood Pressure - Diastolic Blood PressureAsleep58.8 mmHgStandard Deviation 10.2
Primary

Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure

Ambulatory blood pressure monitoring

Time frame: 48 hours

ArmMeasureGroupValue (MEAN)Dispersion
Study GroupChanges Over Time in Ambulatory Blood Pressure - Systolic Blood PressureDifference Day versus Night20.7 mmHgStandard Deviation 3.9
Study GroupChanges Over Time in Ambulatory Blood Pressure - Systolic Blood PressureAwake126.1 mmHgStandard Deviation 10.6
Study GroupChanges Over Time in Ambulatory Blood Pressure - Systolic Blood PressureAsleep106.8 mmHgStandard Deviation 11.6
Primary

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)

Time frame: 3-4 months

ArmMeasureValue (MEAN)
Study GroupMobility Radius6.8 miles
Primary

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.

Time frame: 48 hours

ArmMeasureGroupValue (NUMBER)
Study GroupPercentage of Total MetabolitesPlasma metabolome5.4 percent
Study GroupPercentage of Total MetabolitesSaliva metabolome5.6 percent
Primary

Text Message Length

The total length of all sms messages (sent + received) in characters

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupText Message LengthAwake868.0 n (characters)
Study GroupText Message LengthSleeping47.0 n (characters)
Primary

Text Messages

The number of sms messages (sent + received)

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupText MessagesAwake16.0 messages
Study GroupText MessagesSleeping0.8 messages
Primary

Unanswered Calls

The number of calls unanswered.

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupUnanswered CallsAwake0.6 Unanswered calls
Study GroupUnanswered CallsSleeping0.03 Unanswered calls
Primary

Unique Contacts

The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupUnique ContactsAwake7.2 Unique contacts
Study GroupUnique ContactsSleeping0.5 Unique contacts
Secondary

Changes Over Time in Kidney Function

Time frame: 48 hours

Population: Kidney function was done to evaluate healthy volunteers during Session 1 and 2. Delta was calculated between Session 1 and 2 and averaged across subjects. Note that values for session1 was missing for two subjects, meaning that below reported mean and standard deviation reflect changes for four subjects.

ArmMeasureValue (MEAN)Dispersion
Study GroupChanges Over Time in Kidney Function12.925 mg/dLStandard Deviation 115.468246
Secondary

Changes Over Time in Nutrient Intake - Energy

Nutrient intake will be measured using food photography

Time frame: 48 hours

ArmMeasureGroupValue (MEAN)Dispersion
Study GroupChanges Over Time in Nutrient Intake - EnergySession 11967 KcalsStandard Deviation 488
Study GroupChanges Over Time in Nutrient Intake - EnergySession 21609 KcalsStandard Deviation 601
Secondary

Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH

Time frame: 48 hours

ArmMeasureGroupValue (MEAN)Dispersion
Study GroupChanges Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDHMorning23.3 relative expressionStandard Deviation 13.5
Study GroupChanges Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDHEvening17.9 relative expressionStandard Deviation 9.4
Secondary

Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome

Analysis was performed for all participants as a group.

Time frame: 48 hours

ArmMeasureValue (NUMBER)
Study GroupGenera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome3 genera
Secondary

Physical Activity

Difference in locomotion between wake and sleep times

Time frame: 3-4 months

ArmMeasureGroupValue (MEAN)
Study GroupPhysical ActivityAwake1904.0 Counts/min
Study GroupPhysical ActivitySleeping307.2 Counts/min
Secondary

Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours

Analysis was performed for all participants as a group.

Time frame: 48 hours

ArmMeasureValue (NUMBER)
Study GroupProteins Displaying Different Abundances Measured in the Morning Versus Evening Hours2 Proteins
Secondary

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.

Time frame: 3-4 months

ArmMeasureValue (MEAN)Dispersion
Study GroupSelf-reported Sleep Times [Survey]7.6 hourStandard Deviation 2.9
Secondary

Time Asleep

Hours asleep per each 24 hour period measured by actigraphy

Time frame: 3-4 months

ArmMeasureValue (MEAN)Dispersion
Study GroupTime Asleep7.931449224 hoursStandard Deviation 0.7044404472

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026