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

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study group; Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calls and Text Messages	Aggregate communication as behavioral features has been collected using the cell phone data streams.	3-4 months
Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure	Ambulatory blood pressure monitoring	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.	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)	3-4 months
Calls	Number of phone calls placed and received	3-4 months
Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure	Ambulatory blood pressure monitoring	48 hours
Unanswered Calls	The number of calls unanswered.	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	3-4 months
Call Duration	The duration of calls (made + received)	3-4 months
Text Message Length	The total length of all sms messages (sent + received) in characters	3-4 months
Text Messages	The number of sms messages (sent + received)	3-4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-4 months
Time Asleep	Hours asleep per each 24 hour period measured by actigraphy	3-4 months
Physical Activity	Difference in locomotion between wake and sleep times	3-4 months
Changes Over Time in Nutrient Intake - Energy	Nutrient intake will be measured using food photography	48 hours
Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH		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.	48 hours
Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours	Analysis was performed for all participants as a group.	48 hours
Changes Over Time in Kidney Function		48 hours

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Ginger.io
• Investigators: Principal Investigator: Carsten Skarke, MD, University of Pennsylvania; Principal Investigator: Garret A FitzGerald, MD, University of Pennsylvania; Principal Investigator: Aalim Weljie, PhD, University of Pennsylvania

Publications and helpful links

General 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.

Helpful Links

• Zenodo data repository

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 25, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimated): September 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: blood pressure; human; circadian; metabolism; microbiome; metabolomics; social behavior; oscillation; clock; cell phone with internet access (so-called smartphone); social sensing; behavioral feature; Ginger.io; gut bacteria
• Additional Relevant MeSH Terms: Behavior; Social Behavior
• Other Study ID Numbers: 817759

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No