A Randomized, Double-blind, Placebo-controlled Pilot Study of a Ketone Ester Supplement to Evaluate Muscle and Immune Function in Older Adults at Risk for Strength and Mobility Decline

What this Trial Is About

Researchers are evaluating whether a dietary supplement containing ketones can improve strength and overall wellness in adults aged 65 and older who are experiencing a mild decline in physical function. The study is a randomized, double-blind, placebo-controlled pilot trial designed to assess muscle and immune function in older men and women at risk for decreased strength and mobility. Participants are being enrolled across three sites in the United States and the study is coordinated by the Buck Institute for Research on Aging. Participants are randomly assigned to receive either a ketone ester supplement or a placebo oil daily for 20 weeks. The dosing starts with a lower amount and increases over the first few weeks, eventually reaching 50 grams per day split into two doses taken with the first and last meals of the day. The study includes a screening visit followed by four additional visits, with the ketone ester or placebo consumed at home. Both supplements may cause gastrointestinal side effects in some individuals. Throughout the study, participants provide blood, urine, and stool samples and complete physical performance tests and questionnaires to assess physical function, inflammation markers, cognitive function, mood, sleep quality, and general well-being. Compliance and adverse events are monitored by phone every two weeks between visits. Physical assessments include strength tests, walking tests, and cognitive evaluations. The primary outcome is a frailty composite score measured at baseline, 12 weeks, and 20 weeks, with additional safety and tolerability assessments conducted at multiple time points.

Targeting Aging With a Ketone Ester for Function in Frailty