Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia

Study Overview
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Brief Summary
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The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.

Detailed Description
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A previous study has indicated that Aureobasidium pullulans produced β-glucan may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan 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 6 and 12 weeks of intervention. Eighty adults were administered either 1,000 mg of Aureobasidium pullulans produced β-glucan or a placebo each day for 12 weeks.

Official Title
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Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia: a Randomized Controlled Trial

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Aureobasidium pullulans produced β-glucan group
* Dietary Supplement: placebo group


Participation Criteria
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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 Those who have an average protein intake of 60 g or more/day. Exclusion Criteria: 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) History of fracture during the previous year Uncontrolled hypertension (>160/100 mmHg) Uncontrolled thyroid diseases. History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months History of any central bone fracture within 1 year History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication. Alcohol abuser Allergic reaction to Aureobasidium pullulans produced β-glucan Those who participated in other drug clinical trials within 1 month from the screening date. Severe gastrointestinal symptoms such as heartburn and indigestion Those who are pregnant, lactating, or plan to become pregnant during the clinical trial Those who are judged to be unsuitable by the PI for other reasons

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aureobasidium pullulans produced β-glucan group<br>This group takes Aureobasidium pullulans produced β-glucan for 12 weeks. | Dietary Supplement: Aureobasidium pullulans produced β-glucan group<br>* Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks<br>|
| Placebo Comparator: Placebo group<br>This group takes placebo for 12 weeks. | Dietary Supplement: placebo group<br>* Placebo 300 mg/day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength | the peak torque at 60°/s knee extension (/kg) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appendicular skeletal mass/(height x height) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks | 
| appendicular skeletal mass/weight x 100 | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks | 
| skeletal Muscle Mass Index/(height x height) | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks | 
| concentration of creatinine kinase (IU/L) | creatinine kinase (IU/L) measured at baseline and after 12 weeks | 12 weeks | 
| concentration of lactate (mg/dL) | lactate (IU/L) measured at baseline and after 12 weeks | 12 weeks | 
| EuroQol five dimensional five levels | an index of life quality, minimum, maximum values (0, 1), higher scores mean a better outcome, which will be measured at baseline and after 12 weeks | 12 weeks | 
| concentration of brain-derived neurotrophic factor | brain-derived neurotrophic factor (pg/mL) measured at baseline and after 12 weeks | 12 weeks | 
| concentration of insulin-like growth factor 1 | insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks | 12 weeks | 
| Homeostatic Model Assessment for Insulin Resistance | Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks | 12 weeks |