The Physiological Chronobiome Modified by Age, Sex and Under Evoked Conditions

NCT04225442 | Active Not Recruiting

• 1 other identifier: 834156
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators piloted the characterization of the human chronobiome. Now, this line of research is extended to explore physiological chronobiome modulated by sex, age and under evoked conditions.

Conditions

Healthy; Healthy Aging

Keywords

Chronobiome; Multiomics; Molecular networks; Circadian clocks; Remote sensing

Outcome Measures

Primary Outcomes (1)

• Percent difference in the number of proteins with post-translational modifications found in blood samples from young versus old participants

  High-throughput proteomics analysis determines the number of proteins with and without post-translational modifications. This will explore what effect age has on the number of proteins with post-translational modifications.

  48 hours

Secondary Outcomes (8)

• Percent difference in the number of proteins with post-translational modifications found in blood samples from female versus male participants

  48 hours

• Percent difference in the number of proteins with post-translational modifications found in blood samples from female versus male participants and by age

  48 hours

• Percent difference in environmental light exposure between young versus old participants

  48 hours

• Percent difference in environmental light exposure between young versus old participants and by sex

  48 hours

• Percent difference in physical activity between young versus old participants

  48 hours

Study Arms (1)

Fatty meal

OTHER

To study how a fatty meal modifies the physiological chronobiome in young and old, an isocaloric controlled liquid high fat meal (ICLHFM) will be consumed within 5 min. The ICLHFM contains an equivalent to 35% of the estimated total daily energy requirements (TDE), 60% of kcal delivered from fat while 13% come from protein and 27 % from carbohydrate.

Other: Fatty meal to challenge the physiological chronobiome in healthy young and old

Interventions

Fatty meal to challenge the physiological chronobiome in healthy young and old OTHER

The intervention consists of a fatty meal

Fatty meal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Young: 18-30 years of age, Old: 55-75 years of age
• Apparent healthy
• BMI (body mass index) up to 27.4
• Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ambulatory blood pressure (ABP) measurements,
• Own and use a smartphone.

You may not qualify if:

• History of severe psychiatric illness or cognitive conditions, for example (mania, schizophrenia, or mental retardation;
• Shift work, defined as recurring work between 22:00-05:00;
• A diagnosis of clinically significant obstructive sleep apnea;
• Serum creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women;
• Significant liver disease (\>3x upper limit of normal);
• Diabetes mellitus;
• Past diagnosis of gastroesophageal reflux disease,
• Transmeridian travel across ≥3 time zones in the two weeks before the 48hr deep phenotype sessions;
• Use of oral or intravenous antibiotics in the 6 months prior to enrollment;
• 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;
• \> 2 drinks of alcohol per day;
• Use of drugs assessed in the urinary drug test;
• Nursing or pregnant (pregnancy will be repeatedly assessed at the beginning of each of the four inpatient visits, i.e. prior to the start of blood draws);
• Use of pacemaker or implantable Cardioverter Defibrillator (ICD);
• Bilateral mastectomy;

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

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

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 BACKGROUND

Related Links

• Philadelphia Inquirer

Study Officials

• Garret A FitzGerald, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Carsten C Skarke, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ADJ Research Associate Professor

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: January 5, 2020
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): June 4, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)