Biological AgingTIME-ANCT05760547
The Translational Initiative to Map Epigenetics in Aging (TIME-A)
An observational study of Biological Aging, run by Elysium Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biological Aging
- How many people
- 25,000 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2023to 31 Mar 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults 18 or older
Who may be able to join
- 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
Who cannot join
- Consent to participate not given
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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).
- Conditions
- Biological Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TIME-A | Group will complete periodic surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of environmental and lifestyle factors on biological age
Univariate and multivariate statistical methods will be used to identify which environmental and lifestyle factors (from TIME-A survey responses) influence biological age.
Measured: At baseline and throughout study (approximately every 6 months up to 120 months)
Effect of general health on biological age
Univariate and multivariate statistical methods will be used to identify which general health characteristics (from TIME-A survey responses) influence biological age.
Measured: At baseline and throughout study (approximately every 6 months up to 120 months)
Effect of medical history on biological age
Univariate and multivariate statistical methods will be used to identify the impact of medical history (from TIME-A survey responses) on biological age.
Measured: At baseline and throughout study (approximately every 6 months up to 120 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start8 Mar 2023 (estimated)
- Primary completion31 Mar 2033 (estimated)
- Study completion31 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elysium Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dayle Sampson, PhD, Principal investigator, Elysium HealthHolly Holmes, PhD, Principal investigator, Elysium Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760547
- Sponsor's protocol ID
- TIME-A
- Acronym
- TIME-A
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Translational Initiative to Map Epigenetics in Aging (TIME-A)
- ClinicalTrials.gov ID
- NCT05760547
- Acronym / sponsor ID
- TIME-A / TIME-A
- Conditions
- Biological Aging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Elysium HealthIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (estimated)
- Primary completion
- 31 Mar 2033 (estimated)
- Study completion
- 31 Mar 2033 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIME-A | – | –Group will complete periodic surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 or older
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Consent to participate not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dayle Sampson, PhD principal investigator
Elysium Health
Holly Holmes, PhD principal investigator
Elysium Health
Questions about this trial
What is this clinical trial studying?
An observational study of Biological Aging, run by Elysium Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Dellinger, PhD ((888) 220 6436, care@elysiumhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of environmental and lifestyle factors on biological age (time frame: At baseline and throughout study (approximately every 6 months up to 120 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.