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NCT Number: NCT04994054

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silkworms (Bombyx mori L.) pupae extracts group

Dietary Supplement

silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks

Placebo Group

Dietary Supplement

Placebo 2,400 mg/day for 12 weeks

Primary outcomes

  1. the peak torque at 60°/s knee extension (/kg)

    Time frame: 12 weeks

    conducted on the Biodex System 3 Pro isokinetic dynamometer (Biodex, Inc.)

Secondary outcomes

  1. appendicular skeletal mass/(height x height)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  2. appendicular skeletal mass/weight x 100

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  3. skeletal Muscle Mass Index/(height x height)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  4. concentration of creatinine kinase (IU/L)

    Time frame: 12 weeks

    creatinine kinase (IU/L) measured at baseline and after 12 weeks

  5. concentration of creatine (mg/dL)

    Time frame: 12 weeks

    creatine (mg/dL) measured at baseline and after 12 weeks

  6. EuroQol five dimensional five levels

    Time frame: 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

  7. handgrip strength (kg), right and left

    Time frame: 12 weeks

    using a hydraulic hand dynamometer (Jamar)

  8. body weight (kg)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  9. skeletal musle mass (kg)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  10. total fat percent (%)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  11. truncal fat percent (%)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2021
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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