Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease. The study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.
The overall objective of this study is to evaluate the feasibility, tolerability, metabolic effects, and potential therapeutic potential of isolated valine or EAA in patients with CKD stage 5. * Primary Objective: To evaluate the feasibility, tolerability, and potential therapeutic benefits of isolated valine or EAA for the management of sarcopenia in patients with stage 5 CKD not on dialysis. * Secondary Objectives: To assess the effects of valine and EAA on measures of kidney function and anorexia in patients with stage 5 CKD not on dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Skeletal muscle strength (handgrip strength test)
Change from baseline handgrip strength test value (kg) measured using a hand dynamometer to the end of each 6-Week intervention
Time frame: Baseline to 14 weeks
Muscle mass
Change from baseline muscle mass using a bioelectrical impedance analysis to the end of each 6-Week intervention
Time frame: Baseline to 14 weeks
Physical performance (4-meter Walk Gait Speed Test or 4MWT)
Change from baseline 4MWT (measured in second) to the end of each 6-Week intervention
Time frame: Baseline to 14 weeks
Incidence of patient-reported symptoms
Change from baseline (number of symptoms) to the end of each 6-Week intervention
Time frame: Baseline to 14 weeks
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale
Change from baseline scores (ranging from 0-48, with 0 being the worst possible score) to the end of each 6-Week intervention
Time frame: Baseline to 14 weeks
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