Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aureobasidium pullulans produced β-glucan group This group takes Aureobasidium pullulans produced β-glucan for 12 weeks. |
Dietary Supplement: Aureobasidium pullulans produced β-glucan group
Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks
|
| Placebo Comparator: Placebo group This group takes placebo for 12 weeks. |
Dietary Supplement: placebo group
Placebo 300 mg/day for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- muscle strength [12 weeks]
the peak torque at 60°/s knee extension (/kg)
Secondary Outcome Measures
- appendicular skeletal mass/(height x height) [12 weeks]
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
- appendicular skeletal mass/weight x 100 [12 weeks]
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
- skeletal Muscle Mass Index/(height x height) [12 weeks]
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
- concentration of creatinine kinase (IU/L) [12 weeks]
creatinine kinase (IU/L) measured at baseline and after 12 weeks
- concentration of lactate (mg/dL) [12 weeks]
lactate (IU/L) measured at baseline and after 12 weeks
- EuroQol five dimensional five levels [12 weeks]
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
- concentration of brain-derived neurotrophic factor [12 weeks]
brain-derived neurotrophic factor (pg/mL) measured at baseline and after 12 weeks
- concentration of insulin-like growth factor 1 [12 weeks]
insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks
- Homeostatic Model Assessment for Insulin Resistance [12 weeks]
Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks
Eligibility Criteria
Criteria
Inclusion Criteria:
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<110% of the standard lean body mass as measured using the body composition analyzer
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Body mass index (BMI) ranging from 18.5 to 30.0 kg/m2
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Those who have an average protein intake of 60 g or more/day.
Exclusion Criteria:
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Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
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Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
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History of fracture during the previous year
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Uncontrolled hypertension (>160/100 mmHg)
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Uncontrolled thyroid diseases.
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History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
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History of any central bone fracture within 1 year
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History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
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Alcohol abuser
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Allergic reaction to Aureobasidium pullulans produced β-glucan
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Those who participated in other drug clinical trials within 1 month from the screening date.
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Severe gastrointestinal symptoms such as heartburn and indigestion
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Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
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Those who are judged to be unsuitable by the PI for other reasons
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | Korea, Republic of | 50612 |
Sponsors and Collaborators
- Pusan National University Yangsan Hospital
Investigators
- Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-029-HR