Table 2.

Administration schedules for D-β-hydroxybutyrate-R 1,3-butanediol monoester in single- and repeated dose studies.

Study type	Monoester dose (mg/kg body weight)	Number of doses per day	Number of days	Amount of ketone ester milkshake drink (g/kg)a			Amount of supplemental formula (Ensure®) (g/kg)b
				Dosing	4-h Post-dose	9-h Post-dose	Dosing	4-h Post-dose	9-h Post-dose
Single dose study (N = 6 per dose)	140	1	1	2.69	0	0	8.72	10.90	10.90
	357	1	1	6.87	0	0	5.35	10.90	10.90
	714	1	1	13.73	0	0	0c	10.90	10.90
Repeated dose studye (N = 12 per dose)	420	3	5	2.69	2.69	2.69	8.72	8.72	8.72
	1071	3	5	6.87	6.87	6.87	5.35	5.35	5.35
	2142	3	5	13.73	13.73	13.73	0d	0d	0d

^aThe ketone ester meal replacement milkshake drink contained 84 kcal per 100 g.

^bThe supplemental formula (i.e., Ensure^®) contained 104 kcal per 100 g. The amount of supplemental formula required at each meal was calculated based on a daily caloric requirement of 34 kcal/kg body weight, minus the caloric contribution of the ketone ester milkshake drink.

^cSubjects in the highest dose group (single dose study) had a dose of ketone ester that provided them with one-third of their daily caloric requirements; thus, supplemental formula was not required at dosing.

^dSubjects in the highest dose group (repeated dose study) had their daily caloric requirements met by the ketone ester milkshake drink; thus, supplemental formula was not required during the 5-day dosing period.

^eKetone monoesters were administered as three divided doses of 140 mg/kg bw, 357 mg/kg bw, and 714 mg/kg bw over the course of the day.