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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-05

Study Completion Date

2022-02-28

Brief Summary

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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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Detailed Description

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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

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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silkworms (Bombyx mori L.) pupae extracts group

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

Group Type EXPERIMENTAL

silkworms (Bombyx mori L.) pupae extracts group

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

This group takes placebo for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

Placebo 2,400 mg/day for 12 weeks

Interventions

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silkworms (Bombyx mori L.) pupae extracts group

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

Intervention Type DIETARY_SUPPLEMENT

Placebo group

Placebo 2,400 mg/day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes