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The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan and regular combined exercise on muscle strength, muscle mass, muscle function, and biomarkers in adults with relative sarcopenia for 12 weeks.
A previous human study has indicated that Aureobasidium pullulans produced β-glucan may increase muscle mass and strength in the elderly. Therefore, the investigators will 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, expanding the target population to adults aged 50 and older 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 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 | Dietary Supplement | Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength, 60°/s peak torque (%bodyweight) | 60°/s knee extension peak torque (PT) normalized to bodyweight (BW) (PT/BW), right, left, average and 60°/s knee flextion peak torque normalized to body weight (PT/BW), right, left, average | 12 weeks |
| TUG test | Timed Up & Go test | 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 |
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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 | 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 | Dietary Supplement | Placebo 1,000 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 |
| Hand grip strength, both | Before starting the procedures, the participants were given verbal guidance on how to squeeze the dynamometers to ensure a maximum value. Then, the participants squeezed the dynamometer as hard as possible for three seconds. There were three measurements with 60-second pause intervals between the trials. | 12 weeks |
| Total body fat (%) | Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| Truncal body fat (%) | Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| Muscle power | The peak power at 60°/s knee extension left, right (Nm/s), and flexion left, right (Nm/s) at baseline and after 12 weeks | 12 weeks |
| Skeletal muscle mass (kg) | Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks | 12 weeks |
| Short Physical Performance Battery total score | Short Physical Performance Battery total score at baseline and after 12 weeks. The Short Physical Performance Battery (SPPB) total score ranges from a minimum of 0 to a maximum of 12. A higher score indicates better physical performance, while lower scores reflect greater impairment in physical function. The SPPB assesses lower extremity function through balance tests, gait speed, and chair stand tests. | 12 weeks |
| Gait speed (seconds) | Assessed by timing the participants as they walked 2.44 metres at their regular pace at baseline and after 12 weeks | 12 weeks |
| Repeated chair stand test (seconds) | Timed as they completed five sit-to-stand repetitions at baseline and after 12 weeks | 12 weeks |
| EuroQol five dimensional five levels | 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 insulin-like growth factor 1 | Insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks | 12 weeks |
| Muscle strength, 60°/s peak torque | 60°/s knee extension peak torque (PT), right, left, and average and 60°/s knee flexion peak torque (PT), right, left, and average | 12 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |