Abstract
Abstract
Background: Deeply personalized geroscience requires more than selecting the right intervention. It requires a clinical trial system that connects treatment exposure, longitudinal measurements and clinical oversight to characterize individual responses over time. Establishing whether midlife and older adults can sustain the combined demands of multicomponent treatment and repeated data collection is a foundational step toward this approach. ELITE was an ethics-approved, eight-week, randomized, open-label geroscience trial in 31 adults aged 50–80 without diabetes. It combined repurposed metabolic drugs with two investigational AgeBiotics supplements, AB-01 oral solution and AB-02 capsules, alongside daily app-based data collection and scheduled clinical and biospecimen assessments. This report examines whether participants could sustain this regimen with an acceptable safety profile, presenting the trial’s prespecified safety and feasibility secondary outcomes: adverse events, study completion and overall protocol adherence. Feasibility benchmarks were adherence ≥60% and dropout
Whether such an architecture can be delivered and audited under real clinical conditions remains an important translational question. Intervention-outcome analyses, including the primary MIC-C endpoint and comparisons between randomized arms, are outside the scope of this report and will be presented separately.
Results: Thirty of 31 participants completed follow-up (96.8%; 95% confidence interval, 83.8-99.4), with dropout of 3.2%. All 30 completers (100%) met the ≥60% adherence threshold; their mean overall adherence was 91.5% (standard deviation, 7.4). Corresponding means were 89.4% (13.8) across all 31 randomized participants and 93.3% (5.7) among 25 per-protocol participants. Digital capture occurred on 1,816 of 1,978 observation-window participant-days (91.8%); median digital adherence among completers was 97.7% (interquartile range, 89.1-99.6). Nineteen mild adverse events occurred in 17 participants (54.8%); no serious adverse events were reported. Adverse events led to treatment-component withdrawal or interruption in four participants, who continued study follow-up.
Conclusions: ELITE met its prespecified feasibility benchmarks and demonstrates a practical institutional pathway for integrating repurposed metabolic therapy, sustained longitudinal observation and clinical oversight in response-guided geroscience.
More broadly, the study establishes the operational feasibility of an integrated geroscience architecture combining protocolized multidomain intervention delivery, dense longitudinal measurement, provenance-preserving computation, probabilistic response assessment, physician-supervised governance and monitored clinical close-out.
Trial registration: ISRCTN84791030. Registered 28 September 2026, retrospectively registered.