(P42-48-26) Protocol for the Multivitamin and Epigenetic Age Acceleration Study (VITALITY)

Objectives: To evaluate the effect of daily multivitamin use on epigenetic age (GrimAge) and pace of aging (DunedinPACE) in healthy younger adults with epigenetic age acceleration.

Methods: The multiVitamin epIgeneTic Age acceLeratIon sTudY (VITALITY) is a 6-month, randomized, double-blind, placebo-controlled, parallel clinical trial. A population-based convenience sample of healthy adults aged 30–45 years (N=130) with epigenetic age acceleration will be enrolled from the greater Washington, DC metropolitan area. Participants will be randomized (1:1), stratified by sex, GrimAge, and DunedinPACE, to receive a daily multivitamin (CentrumⓇ formulation developed by investigators) or placebo. Primary outcomes are changes in GrimAge and DunedinPACE from baseline to 6 months. Secondary outcomes include changes in other epigenetic clocks (including those indicative of organ-specific age and factors related to aging and disease risk), DNA-methylation patterns, epigenetic biomarker proxies of clinical health and nutritional status measures, clinical biomarkers of micronutrient status and safety, anthropometrics, blood pressure, and cognitive performance.  Our team plans to biobank blood and fecal samples for future gut microbiome, metabolomic, and lipidomic analyses (pending ancillary grant funding).  Objective daily adherence will be assessed using cloud-based electronic medication monitoring, supplemented by pill counts and self-report.

Results: N/A

Conclusions: A detailed protocol and statistical analysis plan for VITALITY is forthcoming in the peer-reviewed scientific literature.  The trial is registered at www.clinicaltrials.gov (NCTXXX).  IRB documentation, recruitment materials, participant questionnaires, study findings (e.g., presentations and publications), data request forms, and other information pertaining to VITALITY can be found on the trial webpage (www.drtaylorwallace.com/VITALITY).

Funding Sources: Haleon