Clinical trial NCT04994054: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the peak torque at 60°/s knee extension (/kg)
timeFrame: 12 weeks
Secondary outcomes:
measure: appendicular skeletal mass/(height x height)
timeFrame: 12 weeks
measure: appendicular skeletal mass/weight x 100
timeFrame: 12 weeks
measure: skeletal Muscle Mass Index/(height x height)
timeFrame: 12 weeks
measure: concentration of creatinine kinase (IU/L)
timeFrame: 12 weeks
measure: concentration of creatine (mg/dL)
timeFrame: 12 weeks
measure: EuroQol five dimensional five levels
timeFrame: 12 weeks
measure: handgrip strength (kg), right and left
timeFrame: 12 weeks
measure: body weight (kg)
timeFrame: 12 weeks
measure: skeletal musle mass (kg)
timeFrame: 12 weeks
measure: total fat percent (%)
timeFrame: 12 weeks
measure: truncal fat percent (%)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: