SarcopeniaNCT04994054
Effect of Silkworms (Bombyx Mori L.) Pupae Extracts on Musculoskeletal Biomarkers in Adults
A study testing silkworms (Bombyx mori L.) pupae extracts group in people with Sarcopenia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- silkworms (Bombyx mori L.) pupae extracts group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- <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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- silkworms (Bombyx mori L.) pupae extracts group, Placebo group
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silkworms (Bombyx mori L.) pupae extracts groupDietary supplement
silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks
Placebo groupDietary supplement
Placebo 2,400 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| silkworms (Bombyx mori L.) pupae extracts group | Experimental | This group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks. Receives: Dietary Supplement: silkworms (Bombyx mori L.) pupae extracts group |
| Placebo group | Placebo comparator | This group takes placebo for 12 weeks. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the peak torque at 60°/s knee extension (/kg)
conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)
Measured: 12 weeks
Secondary outcomes (11)
appendicular skeletal mass/(height x height)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
appendicular skeletal mass/weight x 100
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
skeletal Muscle Mass Index/(height x height)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
concentration of creatinine kinase (IU/L)
creatinine kinase (IU/L) measured at baseline and after 12 weeks
Measured: 12 weeks
concentration of creatine (mg/dL)
creatine (mg/dL) measured at baseline and after 12 weeks
Measured: 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
Measured: 12 weeks
handgrip strength (kg), right and left
using a hydraulic hand dynamometer (Jamar)
Measured: 12 weeks
body weight (kg)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
skeletal musle mass (kg)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
total fat percent (%)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
truncal fat percent (%)
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start5 Jul 2021
- Primary completion27 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994054
- Sponsor's protocol ID
- 02-2021-023
- Status last verified
- Apr 2023
- First submitted
- 30 Jul 2021
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi JI, Kweon HY, Lee YL, Lee JH, Lee SY. Efficacy of Silkworm Pupae Extract on Muscle Strength and Mass in Middle-Aged and Older Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial. J Nutr Health Aging. 2023;27(7):578-585. doi: 10.1007/s12603-023-1942-9.
PubMed 37498105
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04994054
- Acronym / sponsor ID
- 02-2021-023
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silkworms (Bombyx mori L.) pupae extracts group | Experimental | Dietary Supplement: silkworms (Bombyx mori L.) pupae extracts groupThis group takes silkworms (Bombyx mori L.) pupae extracts for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThis group takes placebo for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- <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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silkworms (Bombyx mori L.) pupae extracts groupsilkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks | Dietary supplement | silkworms (Bombyx mori L.) pupae extracts group |
| Placebo groupPlacebo 2,400 mg/day for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
the peak torque at 60°/s knee extension (/kg)
Time frame: 12 weeks
conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)
11 secondary outcomes
appendicular skeletal mass/(height x height)
Time frame: 12 weeks
appendicular skeletal mass/weight x 100
Time frame: 12 weeks
skeletal Muscle Mass Index/(height x height)
Time frame: 12 weeks
concentration of creatinine kinase (IU/L)
Time frame: 12 weeks
concentration of creatine (mg/dL)
Time frame: 12 weeks
EuroQol five dimensional five levels
Time frame: 12 weeks
handgrip strength (kg), right and left
Time frame: 12 weeks
body weight (kg)
Time frame: 12 weeks
skeletal musle mass (kg)
Time frame: 12 weeks
total fat percent (%)
Time frame: 12 weeks
truncal fat percent (%)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 37498105Choi JI, Kweon HY, Lee YL, Lee JH, Lee SY. Efficacy of Silkworm Pupae Extract on Muscle Strength and Mass in Middle-Aged and Older Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial. J Nutr Health Aging. 2023;27(7):578-585. doi: 10.1007/s12603-023-1942-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing silkworms (Bombyx mori L.) pupae extracts group in people with Sarcopenia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the peak torque at 60°/s knee extension (/kg) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.