Rationale and protocol for a safety, tolerability and feasibility randomized, parallel arm, double-blind, placebo-controlled, pilot study of a novel ketone ester targeting frailty via immunometabolic geroscience mechanisms

This is a protocol for a randomized, placebo-controlled, double-blind, parallel-group pilot trial of a ketone ester in older adults aged 65 and older, with 30 community-dwelling participants to be recruited. Acute 4-hour ketone kinetics will first be assessed after 12.5 g or 25 g of ketone ester, and participants will then be randomized to 25 g ketone ester or a matched placebo once daily for 12 weeks. The primary objective is tolerability, secondary outcomes are safety and acute blood ketone kinetics, and exploratory outcomes include physical and cognitive function, quality of life, aging biomarkers and inflammatory measures.