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

NCT02249793 | Completed Results

• 1 other identifier: 817759
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (8)

• Self-reported Sleep Times [Survey]

  3-4 months

• Time Asleep

  3-4 months

• Physical Activity

  3-4 months

• Changes Over Time in Nutrient Intake - Energy

  48 hours

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

  48 hours

Study Arms (1)

Study group

Healthy volunteers

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Ginger.io: collaborator

Study Sites (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 29215023 RESULT

Related Links

• Zenodo data repository

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, urine, stool, and mucosal swabs from nose, mouth and rectum

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Carsten Skarke
• Organization: Upenn

cskarke@pennmedicine.upenn.edu

215-573-0673

Study Officials

• Carsten Skarke, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Garret A FitzGerald, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Aalim Weljie, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 17, 2026
• Results First Posted: January 18, 2020

Record last verified: 2026-02

Locations

US (1)