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The Translational Initiative to Map Epigenetics in Aging (TIME-A)

Sponsor
Elysium Health (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05760547
Collaborator
(none)
25,000
Enrollment
120.8
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    25000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    The Translational Initiative to Map Epigenetics in Aging (TIME-A)
    Anticipated Study Start Date :
    Mar 8, 2023
    Anticipated Primary Completion Date :
    Mar 31, 2033
    Anticipated Study Completion Date :
    Mar 31, 2033

    Arms and Interventions

    Arm Intervention/Treatment
    TIME-A

    Group will complete periodic surveys

    Outcome Measures

    Primary Outcome Measures

    1. Effect of environmental and lifestyle factors on biological age [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Elysium Health

    Investigators

    • Principal Investigator: Dayle Sampson, PhD, Elysium Health
    • Principal Investigator: Holly Holmes, PhD, Elysium Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elysium Health
    ClinicalTrials.gov Identifier:
    NCT05760547
    Other Study ID Numbers:
    • TIME-A
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 8, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 8, 2023