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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: silkworms (Bombyx mori L.) pupae extracts group; Dietary supplement: Placebo group

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: silkworms (Bombyx mori L.) pupae extracts group; This group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks.	Dietary supplement: silkworms (Bombyx mori L.) pupae extracts group; silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks
Placebo Comparator: Placebo group; This group takes placebo for 12 weeks.	Dietary supplement: Placebo group; Placebo 2,400 mg/day for 12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): February 27, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 02-2021-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No