Effect of Silkworms (Bombyx Mori L.) Pupae Extracts on Musculoskeletal Biomarkers in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Silkworms (Bombyx Mori L.) Pupae Extracts on Musculoskeletal Biomarkers in Adults With With Relatively Low Muscle Mass: a Randomized, Double-blinded, Placebo-controlled Trial

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: silkworms (Bombyx mori L.) pupae extracts group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <110% of the standard lean body mass as measured using the body composition analyzer Body mass index (BMI) ranging from 18.5 to 30.0 kg/m2 Exclusion Criteria: Vegetarian History of any central bone fracture within 1 year History of cancer or serious cerebro-cardiovascular diseases within 6 months Abnormal liver or renal function (more than twice the normal upper limit of the research institute) Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar) Uncontrolled hypertension (>160/100 mmHg) Uncontrolled thyroid diseases. History of medication for psychiatric diseases such as severe affective disorder, schizophrenia, and substance use. Alcohol abuser Allergic reaction to constituent foods Severe gastrointestinal symptoms such as heartburn and indigestion Those who are pregnant, lactating, or planning to become pregnant during the clinical trial Those who have participated in other drug clinical trials within the last 3months

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silkworms (Bombyx mori L.) pupae extracts group<br>This group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks. | Dietary Supplement: silkworms (Bombyx mori L.) pupae extracts group<br>* silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks<br>|
| Placebo Comparator: Placebo group<br>This group takes placebo for 12 weeks. | Dietary Supplement: Placebo group<br>* Placebo 2,400 mg/day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |