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Trial record 1 of 1 for:    NCT05760547
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The Translational Initiative to Map Epigenetics in Aging (TIME-A) (TIME-A)

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ClinicalTrials.gov Identifier: NCT05760547
Recruitment Status : Not yet recruiting
First Posted : March 8, 2023
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Elysium Health

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The Translational Initiative to Map Epigenetics in Aging (TIME-A) study aims to advance our understanding of the connections between epigenetics, lifestyle, demographics, and health and aging.

Condition or disease
Biological Aging

Detailed Description:
TIME-A is a longitudinal research initiative. Anyone who has ever taken an Index test registered through Elysium Health is eligible to participate. Participation involves answering questions that will be administered via a survey format. Research participants' survey responses will be combined with their epigenetic Index data with the primary aim of identifying the contributions of 1) environmental and lifestyle factors, 2) general health, and 3) medical history, on biological age. Exploratory aims include the development of epigenetic signatures that are predictive of health status, and exploring the relationship between epigenetically-derived health phenotypes and biological age. These findings will lay the foundation for personalized health recommendations using Index (including, but not limited to: workout routines, diets, supplement regimens, medications, lifestyle changes).
Study Design
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Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Translational Initiative to Map Epigenetics in Aging (TIME-A)
Estimated Study Start Date : March 8, 2023
Estimated Primary Completion Date : March 31, 2033
Estimated Study Completion Date : March 31, 2033

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
TIME-A
Group will complete periodic surveys


Outcome Measures
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Primary Outcome Measures :
  1. Effect of environmental and lifestyle factors on biological age [ Time Frame: At baseline and throughout study (approximately every 6 months up to 120 months) ]
    Univariate and multivariate statistical methods will be used to identify which environmental and lifestyle factors (from TIME-A survey responses) influence biological age.

  2. Effect of general health on biological age [ Time Frame: At baseline and throughout study (approximately every 6 months up to 120 months) ]
    Univariate and multivariate statistical methods will be used to identify which general health characteristics (from TIME-A survey responses) influence biological age.

  3. Effect of medical history on biological age [ Time Frame: At baseline and throughout study (approximately every 6 months up to 120 months) ]
    Univariate and multivariate statistical methods will be used to identify the impact of medical history (from TIME-A survey responses) on biological age.


Other Outcome Measures:
  1. Develop epigenetic signatures that are predictive of health status [ Time Frame: At baseline and throughout study (approximately every 6 months up to 120 months) ]
    DNA methylation data and TIME-A survey responses will be combined. Supervised and unsupervised machine learning methods will be used to generate novel methylation-derived predictors of participants' survey responses.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults 18 or older
Criteria

Inclusion Criteria:

  • All adults aged 18 and above
  • Have registered at least one Index kit via the Elysium Health website
  • Able and willing to provide digital consent to the Research Consent Form, and the TIME-A Research Subject Consent Form

Exclusion Criteria:

  • Consent to participate not given
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05760547


Contacts
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Contact: Ryan Dellinger, PhD (888) 220 6436 care@elysiumhealth.com

Sponsors and Collaborators
Elysium Health
Investigators
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Principal Investigator: Dayle Sampson, PhD Elysium Health
Principal Investigator: Holly Holmes, PhD Elysium Health
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Elysium Health
ClinicalTrials.gov Identifier: NCT05760547    
Other Study ID Numbers: TIME-A
First Posted: March 8, 2023    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No