TABLE 6.

Progression of clinical measures in relation to changed or stable body composition over 6 mo in subjects from Cohort #3¹

	Change in clinical measures (6 mo–baseline)
Body composition	Weight, kg	BMI, kg/m2	ALSFRS-R	Predicted FVC2
By ALS-specific equation
FM reduction > 2.5%	−5.9 ± 4.8	−2.0 ± 1.7	−5.9 ± 6.2	−14.8 ± 19.8
FM stable or gained	2.2 ± 2.4	0.8 ± 0.9	−3.1 ± 4.6	−8.8 ± 19.6
P value3	<0.001	<0.001	0.001	0.04
LBM reduction > 2.5%	−8.2 ± 4.7	−2.7 ± 1.7	−8.3 ± 7.5	−21.8 ± 19.4
LBM stable or gained	0.7 ± 4.8	0.3 ± 1.7	−3.5 ± 4.6	−9.7 ± 18.6
P value3	<0.001	<0.001	<0.001	0.001
By Deurenberg equations
FM reduction > 2.5%	−6.1 ± 4.9	−2.1 ± 1.6	−6.0 ± 6.3	−15.2 ± 20.1
FM stable or gained	2.0 ± 2.5	0.7 ± 0.9	−3.1 ± 4.6	−8.7 ± 19.3
P value3	<0.001	<0.001	<0.001	0.03
LBM reduction > 2.5%	−7.8 ± 5.1	−2.6 ± 1.8	−7.4 ± 7.1	−17.3 ± 19.7
LBM stable or gained	0.3 ± 3.7	0.1 ± 1.4	−3.3 ± 4.5	−9.8 ± 19.4
P value3	<0.001	<0.001	<0.001	0.02

¹ n = 213. Values are means ± SDs unless indicated otherwise. ALS, amyotrophic lateral sclerosis; ALSFRS-R, ALS functional rating scale-revised (normal = 48); FM reduction, >2.5% decrease in fat mass compared with baseline; FM stable or gained, <2.5% decrease or an increase in fat mass compared with baseline; FVC, forced vital capacity; LBM reduction, >2.5% decrease in lean body mass compared with baseline; LBM stable or gained, <2.5% decrease or an increase in lean body mass compared with baseline.

²Percentage corrected for age, sex, and height.

³ P values are from t tests comparing FM reduction > 2.5% with FM stable or gained groups.