The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of silkworms (Bombyx mori L.) pupae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.
A previous study has indicated that silkworms (Bombyx mori L.) pupae extracts may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of silkworms (Bombyx mori L.) pupae extracts 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 12 weeks of intervention. Fifty four adults were administered either 2,400 mg of silkworms (Bombyx mori L.) pupae extracts or a placebo each day for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks
Placebo 2,400 mg/day for 12 weeks
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea
the peak torque at 60°/s knee extension (/kg)
conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)
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 creatine (mg/dL)
creatine (mg/dL) measured at baseline and after 12 weeks
Time frame: 12 weeks
EuroQol five dimensional five levels
an index of life quality, minimum, maximum values (-0.171, 1), higher scores mean a better outcome, which will be measured at baseline and after 12 weeks
Time frame: 12 weeks
handgrip strength (kg), right and left
using a hydraulic hand dynamometer (Jamar)
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Time frame: 12 weeks
body weight (kg)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time frame: 12 weeks
skeletal musle mass (kg)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time frame: 12 weeks
total fat percent (%)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time frame: 12 weeks
truncal fat percent (%)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time frame: 12 weeks