The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.
A previous study has indicated that Aureobasidium pullulans produced β-glucan may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia; the safety of the compound are also evaluated. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 1,000 mg of Aureobasidium pullulans produced β-glucan or a placebo each day for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks
Placebo 300 mg/day for 12 weeks
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea
muscle strength
the peak torque at 60°/s knee extension (/kg)
Time frame: 12 weeks
appendicular skeletal mass/(height x height)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time frame: 12 weeks
appendicular skeletal mass/weight x 100
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time frame: 12 weeks
skeletal Muscle Mass Index/(height x height)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time frame: 12 weeks
concentration of creatinine kinase (IU/L)
creatinine kinase (IU/L) measured at baseline and after 12 weeks
Time frame: 12 weeks
concentration of lactate (mg/dL)
lactate (IU/L) measured at baseline and after 12 weeks
Time frame: 12 weeks
EuroQol five dimensional five levels
an index of life quality, minimum, maximum values (0, 1), higher scores mean a better outcome, which will be measured at baseline and after 12 weeks
Time frame: 12 weeks
concentration of brain-derived neurotrophic factor
brain-derived neurotrophic factor (pg/mL) measured at baseline and after 12 weeks
Time frame: 12 weeks
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concentration of insulin-like growth factor 1
insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks
Time frame: 12 weeks
Homeostatic Model Assessment for Insulin Resistance
Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks
Time frame: 12 weeks