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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994054
• Other study ID #: 02-2021-023
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2023
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 28, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• silkworms (Bombyx mori L.) pupae extracts group
silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks
• Placebo group
Placebo 2,400 mg/day for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the peak torque at 60°/s knee extension (/kg)	conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)	12 weeks
Secondary	appendicular skeletal mass/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	appendicular skeletal mass/weight x 100	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	skeletal Muscle Mass Index/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	concentration of creatinine kinase (IU/L)	creatinine kinase (IU/L) measured at baseline and after 12 weeks	12 weeks
Secondary	concentration of creatine (mg/dL)	creatine (mg/dL) measured at baseline and after 12 weeks	12 weeks
Secondary	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
Secondary	handgrip strength (kg), right and left	using a hydraulic hand dynamometer (Jamar)	12 weeks
Secondary	body weight (kg)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	skeletal musle mass (kg)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	total fat percent (%)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	truncal fat percent (%)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks