Pilot Study of the ICOPE Intense Program with Ketone Ester Supplementation to Support Healthy Aging and Improve Mobility, Cognition, and Immunity

What this Trial Is About

Researchers are exploring a model called ICOPE to promote healthy aging by preventing declines in immunity, mobility, and cognitive function. This pilot study aims to measure the maximum impact that a strong non-drug intervention, combined with nutritional ketone supplementation, can have on key aging functions. The findings will serve as a reference for future studies on new anti-aging drugs or other nonpharmacological approaches. Participants receive one of four treatments the intense ICOPE program alone, the intense ICOPE program plus ketone ester supplements, the usual ICOPE Step 1 program plus ketone supplements, or the usual ICOPE Step 1 program with a placebo. The intense program includes 45 hours of center-based group sessions, daily home lifestyle improvements, and weekly support calls. Ketone ester dosing starts with 12.5g daily in the first week, increasing to 25g daily for weeks 2 through 8. Additional dietary supplements like vitamin D3, omega-3, vitamins B9 and B12, and leucine-rich whey may be provided as needed. During the 60-day study, participants will be assessed on cognitive, muscle, and immune function to estimate the size of the interventions effects. Evaluations include physical tests, cognitive screening, and monitoring of supplement adherence. Safety and ability to participate are closely monitored, with eligibility requiring independent living and certain mobility and cognitive criteria. The total study involvement lasts about two months, focusing on how the combined interventions influence aging-related functions.

ICOPE INTENSE-K Pilot Study