Daily consumption of ketone ester, bis-octanoyl (R)-1,3-butanediol, is safe and tolerable in healthy older adults in a randomized, parallel arm, double-blind, placebo-controlled, pilot study

In this randomized, parallel-arm, double-blind, placebo-controlled pilot trial, 30 community-dwelling older adults (age 76 y, range 65 to 90 y) were randomized, and 23 completed the protocol. They consumed either 25 g of bis-octanoyl (R)-1,3-butanediol ketone ester or a calorie-matched canola oil placebo daily for 12 weeks. The primary outcome, moderate or severe nausea, headache or dizziness on more than one day in a two-week period, was reported by 2 participants (14.3 percent) on ketone ester and 1 (7.1 percent) on placebo. Symptoms were more frequent in the first two weeks, there were four dropouts in the placebo group and two in the ketone ester group, and there were no clinically relevant changes in safety labs or vital signs.