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

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
silkworms (Bombyx mori L.) pupae extracts group
Placebo group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
  • Those who have an average protein intake of 60 g or more/day.

Exclusion Criteria:

  • 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)
  • History of fracture during the previous year
  • Uncontrolled hypertension (>160/100 mmHg)
  • Uncontrolled thyroid diseases.
  • History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
  • History of any central bone fracture within 1 year
  • History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
  • Alcohol abuser
  • Allergic reaction to silkworms (Bombyx mori L.) pupae
  • Those who participated in other drug clinical trials within 1 month from the screening date.
  • Severe gastrointestinal symptoms such as heartburn and indigestion
  • Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
  • Those who are judged to be unsuitable by the PI for other reasons

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

silkworms (Bombyx mori L.) pupae extracts group

Placebo group

Arm Description

This group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks.

This group takes placebo for 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2021
Last Updated
April 29, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04994054
Brief Title
Effect of Silkworms (Bombyx Mori L.) Pupae Extracts on Musculoskeletal Biomarkers in Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
February 27, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
silkworms (Bombyx mori L.) pupae extracts group
Arm Type
Experimental
Arm Description
This group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
silkworms (Bombyx mori L.) pupae extracts group
Intervention Description
silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
Placebo 2,400 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
the peak torque at 60°/s knee extension (/kg)
Description
conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
appendicular skeletal mass/(height x height)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
appendicular skeletal mass/weight x 100
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
skeletal Muscle Mass Index/(height x height)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
concentration of creatinine kinase (IU/L)
Description
creatinine kinase (IU/L) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
concentration of creatine (mg/dL)
Description
creatine (mg/dL) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
EuroQol five dimensional five levels
Description
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
Time Frame
12 weeks
Title
handgrip strength (kg), right and left
Description
using a hydraulic hand dynamometer (Jamar)
Time Frame
12 weeks
Title
body weight (kg)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
skeletal musle mass (kg)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
total fat percent (%)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
truncal fat percent (%)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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