For the RCT, we first propose a two-arm randomized controlled pilot trial that will enroll 50 participants for the XPRIZE Semi-Finals to evaluate the effects of our personalized multimodal lifestyle intervention combined with metformin. After a screening process on 5 criteria to pre-select on accelerated aging, assessments will be conducted at baseline, and after 2 months of the intervention. We will examine clinical outcomes related to muscle, cognitive, and immune function as primary outcomes, as well as biological aging of these functions.
The findings from this Semi-Finals trial will inform the design and implementation of the larger trial in the Finals testing. Additionally – to extend the evidence-base of our solution, we perform target trial emulations of our intervention exploiting data sets of
7 prospective cohorts
- SHIP-Age NCT05962203
- Berlin Aging Study (BASE-I) &
- Berlin Aging Study (BASE-II)
- Nurses’ Health Study
- SHIP–Start
- SHIP-Trend
- The Dunedin Study
and 10 clinical trials
- DO-HEALTH NCT01745263
- ASPREE-XT
- STAREE
- SPRINT
- PIKASO NCT06096259
- STRONG NCT03417531
- Move for your Mind NCT03384602
- T&D NCT 02419105
- Zurich Knee OA Vitamin D trial Zurich Knee OA vitamin D trial
- Boston STOP-IT