Sarcopenia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAureobasidium pullulans produced β-glucan
Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo 1,000 mg/day for 12 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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 * Grip strength of the frequently used hand is based on the following age-specific standards: Men in their 50s (less than 42 kg, women: less than 25.1 kg), Men in their 60s (less than 38.5 kg, women: less than 24.1 kg), Men 70 and older (less than 33.2 kg, women: less than 20.9 kg) * Individuals with a Short Physical Performance Battery score of 9 or higher.
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, and 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength, 60°/s peak torque (%bodyweight) | 12 weeks | 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 |
| TUG test | 12 weeks | Timed Up \& Go test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Hand grip strength, both | 12 weeks | 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. |
| Total body fat (%) | 12 weeks | Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks |
| Truncal body fat (%) | 12 weeks | Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks |
| Muscle power | 12 weeks | The peak power at 60°/s knee extension left, right (Nm/s), and flexion left, right (Nm/s) at baseline and after 12 weeks |
| Skeletal muscle mass (kg) | 12 weeks | Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks |
| Short Physical Performance Battery total score | 12 weeks | 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. |
| Gait speed (seconds) | 12 weeks | Assessed by timing the participants as they walked 2.44 metres at their regular pace at baseline and after 12 weeks |
| Repeated chair stand test (seconds) | 12 weeks | Timed as they completed five sit-to-stand repetitions at baseline and after 12 weeks |
| EuroQol five dimensional five levels | 12 weeks | 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 insulin-like growth factor 1 | 12 weeks | Insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks |
| Muscle strength, 60°/s peak torque | 12 weeks | 60°/s knee extension peak torque (PT), right, left, and average and 60°/s knee flexion peak torque (PT), right, left, and average |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSang Yeoup Lee, MD, PhD
Pusan National University Yangsan Hospital
Outcome results
None listed