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

Biological Aging Clinical Trial

— TIME-A  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05760547
• Other study ID #: TIME-A
• Status: Not yet recruiting
• Start date: March 8, 2023
• Est. completion date: March 31, 2033

Study information

• Verified date: February 2023
• Source: Elysium Health
• Contact: Ryan Dellinger, PhD
• Phone: (888) 220 6436
• Email: care[@]elysiumhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25000
• Est. completion date: March 31, 2033
• Est. primary completion date: March 31, 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biological Aging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elysium Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Develop epigenetic signatures that are predictive of health status	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.	At baseline and throughout study (approximately every 6 months up to 120 months)
Primary	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.	At baseline and throughout study (approximately every 6 months up to 120 months)
Primary	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.	At baseline and throughout study (approximately every 6 months up to 120 months)
Primary	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.	At baseline and throughout study (approximately every 6 months up to 120 months)