Table 2

Anthropometric, patient-reported, and clinical outcome measures using an intention-to-treat analysis pre-KD and post-KD intervention

	Baseline (pre-diet) (n=64)	3 months (on-diet) (n=59)		6 months (on-diet) (n=57)
	Mean±SD	∆ Change from baseline	P value	∆ Change from baseline	P -value
Anthropometric measures
Body Mass Index (BMI)	33.2±7.0	−2.9±1.5	<0.001	−3.4±2.2	<0.001
Waist Circumference (cm)	104.8±14.2	−6.7±5.2	<0.001	−9.8±7.4	<0.001
Bod Pod Assessment
Fat Mass (kg)	41.3±16.1	—	—	−7.7±5.4	<0.001
Fat-Free Mass (kg)	51.9±10.7	—	—	−1.4±1.9	<0.001
Resting Metabolic Rate (kcal/day)	1510.8±306.2	—	—	−67.8±60.1	<0.001
Patient reported outcomes
Beck’s Depression Inventory	8.5±5.3	−3.3±3.8	<0.001	−3.8±4.5	<0.001
Modified Fatigue Impact Scale	33.3±18.1	−11.6±12.7	<0.001	−14.4±14.9	<0.001
MS Fatigue Severity Scale*	21.9±8.8	−2.7±5.4	0.015	−3.4±5.8	0.002
MS Quality of Life-54*
Physical QoL	66.9±16.3	+9.2 ± 10.3	<0.001	+12.0 ± 14.0	<0.001
Mental QoL	71.3±16.6	+8.5 ± 13.6	0.002	+11.2 ± 18.3	<0.001
Clinical outcome measures
EDSS	2.3±0.9	−0.4±0.6	<0.001	−0.5±0.6	<0.001
MS Functional Composite
Timed 25-foot walk (sec)	5.0±1.5	—	—	−0.1±0.7	0.33
9-Hole Peg Test (sec)	21.5±3.6	—	—	−1.1±1.5	<0.001
PASAT (# correct)	46.6±9.0	—	—	+0.2 ± 4.9	0.815
SDMT (# correct)	61.1±10.1	—	—	+1.1 ± 5.6	0.18
6 min walk (feet)	1631±302	—	—	+78 ± 137	<0.001
Low Contrast Visual Acuity
100 OU (# correct)	56±9	—	—	+0.6 ± 5	0.355
2.5 OU (# correct)	36±11	—	—	+0.2 ± 6	0.856
1.25 OU (# correct)	27±12	—	—	+1.2 ± 10	0.390

Results represent mean±SD as change from baseline to reported time point (eg, 3 months or 6 months on KD).
Bolded denotes a significant p-value.
*These surveys were only completed on the last 45 subjects, such that at baseline n=44, 3 months n=40 and 6 months n=39.
†
EDSS, Expanded Disability Status Scale; KD, ketogenic diet; MS, multiple sclerosis; SDMT, Symbol Digit Modality Test.