HMB Cerebral Palsy Pilot Study

β-hydroxy-β-methylbutyrate (HMB) Pilot Feasibility and Efficacy Study in Cerebral Palsy (CP)

This is a pilot study of β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3 supplementation in adolescents with cerebral palsy. The primary objective is to quantify safety, compliance, and acceptability of daily combined HMB + Vitamin D3 supplementation for 12 weeks in adolescents with CP. The secondary objective is to quantify changes in lower extremity muscle mass, strength, and functional mobility after daily combined HMB + Vitamin D3 supplementation for 12 weeks.

Inclusion Criteria:

• Diagnosed with cerebral palsy
• Spastic or mixed tone
• GMFCS Level I-III (i.e., ambulatory)
• 13-17 years old
• Physical training level expected to remain relatively constant over the study period
• Ability to follow directions, including swallowing multiple pills daily and complying with reproductive risk recommendations (post-menarchal females)
• Within reasonable driving distance to the University of Minnesota - Twin Cities
• Reads English

Exclusion Criteria:

• Pregnant, lactating, or trying to become pregnant
• Surgery in the past 9 months
• Botulinum toxin injections in past 3 months
• Selective dorsal rhizotomy in the past 12 months
• Upcoming invasive treatment within the study period that may affect strength or functional mobility (e.g., surgery, botulinum toxin injections, intrathecal baclofen pump or dosage change)
• Liver disease or liver disorder
• Kidney disease or disorder
• Prescription drug or nutrition supplement contraindications
• Excessive research or medical-related radiation exposure in the past 12 months (approximately 500 mrem or greater)