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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aureobasidium pullulans produced β-glucan group | Experimental | This group takes Aureobasidium pullulans produced β-glucan for 12 weeks. |
|
| Placebo group | Placebo Comparator | This group takes placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aureobasidium pullulans produced β-glucan group | Dietary Supplement | Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| muscle strength | the peak torque at 60°/s knee extension (/kg) | 12 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| waist circumference | waist circumference (cm) measured at baseline and after 12 weeks | 12 weeks |
| total cholesterol | total cholesterol (mg/dL) measured at baseline and after 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| placebo group | Dietary Supplement | Placebo 300 mg/day for 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 |
| 12 weeks |
| Triglyceride | Triglyceride (mg/dL) measured at baseline and after 12 weeks | 12 weeks |
| high-density lipoprotein cholesterol | high-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks | 12 weeks |
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks | 12 weeks |
| short physical performance battery | short physical performance battery (second) measured at baseline and after 12 weeks | 12 weeks |
| Sit-up | Sit-up (count) measured at baseline and after 12 weeks | 12 weeks |
| sit and reach | sit and reach (cm) measured at baseline and after 12 weeks | 12 weeks |
| single leg stance | sit and reach (second) measured at baseline and after 12 weeks | 12 weeks |
| 6-min walk test | 6-min walk test (meter) measured at baseline and after 12 weeks | 12 weeks |
| 400-meter walk test | 400-meter walk test (second) measured at baseline and after 12 weeks | 12 weeks |
| 10-meter obstacle walk test | 10-meter obstacle walk test (second) measured at baseline and after 12 weeks | 12 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |