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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silkworms (Bombyx mori L.) pupae extracts group | Experimental | This group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks. |
|
| Placebo group | Placebo Comparator | This group takes placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silkworms (Bombyx mori L.) pupae extracts group | Dietary Supplement | silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| the peak torque at 60°/s knee extension (/kg) | conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| appendicular skeletal mass/(height x height) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| appendicular skeletal mass/weight x 100 | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37498105 | Derived | Choi JI, Kweon HY, Lee YL, Lee JH, Lee SY. Efficacy of Silkworm Pupae Extract on Muscle Strength and Mass in Middle-Aged and Older Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial. J Nutr Health Aging. 2023;27(7):578-585. doi: 10.1007/s12603-023-1942-9. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Placebo group | Dietary Supplement | Placebo 2,400 mg/day for 12 weeks |
|
| 12 weeks |
| skeletal Muscle Mass Index/(height x height) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| concentration of creatinine kinase (IU/L) | creatinine kinase (IU/L) measured at baseline and after 12 weeks | 12 weeks |
| concentration of creatine (mg/dL) | creatine (mg/dL) measured at baseline and after 12 weeks | 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 | 12 weeks |
| handgrip strength (kg), right and left | using a hydraulic hand dynamometer (Jamar) | 12 weeks |
| body weight (kg) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| skeletal musle mass (kg) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| total fat percent (%) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| truncal fat percent (%) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |