Clinical trial NCT02249793: Exploratory Study of Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
Official title: Exploratory Study in Healthy Volunteers to Define Circadian Relationships Between Social Behavior, Blood Pressure and Metabolomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Ginger.io
First posted: 2014-09-26
Enrollment: 6
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Calls and Text Messages
timeFrame: 3-4 months
measure: Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure
timeFrame: 48 hours
measure: Percentage of Total Metabolites
timeFrame: 48 hours
measure: Mobility Radius
timeFrame: 3-4 months
measure: Calls
timeFrame: 3-4 months
measure: Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure
timeFrame: 48 hours
measure: Unanswered Calls
timeFrame: 3-4 months
measure: Unique Contacts
timeFrame: 3-4 months
measure: Call Duration
timeFrame: 3-4 months
measure: Text Message Length
timeFrame: 3-4 months
measure: Text Messages
timeFrame: 3-4 months
Secondary outcomes:
measure: Self-reported Sleep Times [Survey]
timeFrame: 3-4 months
measure: Time Asleep
timeFrame: 3-4 months
measure: Physical Activity
timeFrame: 3-4 months
measure: Changes Over Time in Nutrient Intake - Energy
timeFrame: 48 hours
measure: Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH
timeFrame: 48 hours
measure: Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome
timeFrame: 48 hours
measure: Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours
timeFrame: 48 hours
measure: Changes Over Time in Kidney Function
timeFrame: 48 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Carsten Skarke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Garret A FitzGerald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Aalim Weljie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.