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

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.

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.