Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults

In a 28-day, randomized, double-blind, placebo-controlled, parallel trial, 59 healthy adults consumed a beverage containing the ketone diester bis-hexanoyl-(R)-1,3-butanediol (BH-BD) or a taste-matched placebo daily with breakfast, at 12.5 g on days 0 to 7 and 25 g on days 7 to 28. Tolerability, stimulation, and sedation were assessed daily by questionnaire, and blood and urine were collected for safety assessment. There were no differences between BH-BD and placebo in composite systemic and gastrointestinal tolerability scores, stimulation, or sedation, and scores did not change when servings were doubled. BH-BD significantly increased blood ketones 1 hour after consumption.