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

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: silkworms (Bombyx mori L.) pupae extracts group; Dietary Supplement: Placebo group

• Registration Number: NCT04994054
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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

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 Timeline

• Study Start: 2021-07-05
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-06
• Primary Completion: 2022-02-27
• Study Completion: 2022-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-29
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silkworms (Bombyx mori L.) pupae extracts group	silkworms (Bombyx mori L.) pupae extracts group	This group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks.
Placebo group	Placebo group	This group takes placebo for 12 weeks.

Primary Outcome Measures

Name	Time	Method
the peak torque at 60°/s knee extension (/kg)	12 weeks	conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)

Secondary Outcome Measures

Name	Time	Method
appendicular skeletal mass/weight x 100	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
concentration of creatine (mg/dL)	12 weeks	creatine (mg/dL) measured at baseline and after 12 weeks
handgrip strength (kg), right and left	12 weeks	using a hydraulic hand dynamometer (Jamar)
total fat percent (%)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
appendicular skeletal mass/(height x height)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
skeletal Muscle Mass Index/(height x height)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
concentration of creatinine kinase (IU/L)	12 weeks	creatinine kinase (IU/L) measured at baseline and after 12 weeks
EuroQol five dimensional five levels	12 weeks	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
body weight (kg)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
skeletal musle mass (kg)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
truncal fat percent (%)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of