Sarcopenia
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTAureobasidium pullulans produced β-glucan group
Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks
DIETARY_SUPPLEMENTplacebo group
Placebo 300 mg/day for 12 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle strength | 12 weeks | the peak torque at 60°/s knee extension (/kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| appendicular skeletal mass/(height x height) | 12 weeks | using dual-energy X-ray absorptiometry 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 400-meter walk test | 12 weeks | 400-meter walk test (second) measured at baseline and after 12 weeks |
| waist circumference | 12 weeks | waist circumference (cm) measured at baseline and after 12 weeks |
| 10-meter obstacle walk test | 12 weeks | 10-meter obstacle walk test (second) measured at baseline and after 12 weeks |
| total cholesterol | 12 weeks | total cholesterol (mg/dL) measured at baseline and after 12 weeks |
| Triglyceride | 12 weeks | Triglyceride (mg/dL) measured at baseline and after 12 weeks |
| high-density lipoprotein cholesterol | 12 weeks | high-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks |
| low-density lipoprotein cholesterol | 12 weeks | low-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks |
| short physical performance battery | 12 weeks | short physical performance battery (second) measured at baseline and after 12 weeks |
| Sit-up | 12 weeks | Sit-up (count) measured at baseline and after 12 weeks |
| sit and reach | 12 weeks | sit and reach (cm) measured at baseline and after 12 weeks |
| single leg stance | 12 weeks | sit and reach (second) measured at baseline and after 12 weeks |
| 6-min walk test | 12 weeks | 6-min walk test (meter) measured at baseline and after 12 weeks |
Countries
South Korea
Outcome results
None listed