This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
60
Catalina Research Institute, LLC
Montclair, California, United States
Orange County Research Center
Tustin, California, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline to Week 12
Change in muscle mass by MRI
Time frame: Baseline to Week 12
Change in Fischer's ratio [measured by ratio of branched-chain amino acids (leucine, valine, isoleucine) to aromatic amino acids (phenylalanine, tyrosine)]
Time frame: Baseline to Week 12
Change in plasma ammonia
Time frame: Baseline to Week 12
Change in blood urea nitrogen concentration
Time frame: Baseline to Week 12
Change in creatinine concentration
Time frame: Baseline to Week 12
Change in gait speed
Time frame: Baseline to Week 12
Change in Liver Frailty Index
Time frame: Baseline to Week 12
Change in overall physical activity (measured by actigraphy watch)
Time frame: Baseline to Week 12
Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES)
Time frame: Baseline to Week 12
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OMEGA Research Maitland, LCC
Orlando, Florida, United States
Avita Clinical Research
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Indiana University Health
Indianapolis, Indiana, United States
Delta Research Partners
Bastrop, Louisiana, United States
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania, United States
Texas Liver Institute
San Antonio, Texas, United States
...and 1 more locations