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

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: silkworms (Bombyx mori L.) pupae extracts group

Study type: Interventional

Funder types: Other

Identifiers

NCT04994054

02-2021-023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

silkworms (Bombyx mori L.) pupae extracts group

Experimental group

Description:

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

Treatment:

Dietary Supplement: silkworms (Bombyx mori L.) pupae extracts group

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 12 weeks.

Treatment:

Dietary Supplement: Placebo group