SarcopeniaNCT06629805
β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults
A study testing Aureobasidium pullulans produced β-glucan in people with Sarcopenia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Aureobasidium pullulans produced β-glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- <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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: Effect of Aureobasidium Pullulans Produced β-glucan and Regular Combined Exercise on Musculoskeletal Function and Biomarkers in Adults With Relative Sarcopenia: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Aureobasidium pullulans produced β-glucan, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aureobasidium pullulans produced β-glucanDietary supplement
Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks
PlaceboDietary supplement
Placebo 1,000 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aureobasidium pullulans produced β-glucan group | Experimental | This group takes Aureobasidium pullulans produced β-glucan for 12 weeks. Receives: Dietary Supplement: Aureobasidium pullulans produced β-glucan |
| Placebo group | Placebo comparator | This group takes placebo for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
TUG test
Timed Up \& Go test
Measured: 12 weeks
Secondary outcomes (14)
Appendicular skeletal mass/(height x height)
Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
Appendicular skeletal mass/weight x 100
Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
Skeletal Muscle Mass Index/(height x height)
Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 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.
Measured: 12 weeks
Total body fat (%)
Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 12 weeks
Truncal body fat (%)
Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 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
Measured: 12 weeks
Skeletal muscle mass (kg)
Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Measured: 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.
Measured: 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
Measured: 12 weeks
Repeated chair stand test (seconds)
Timed as they completed five sit-to-stand repetitions at baseline and after 12 weeks
Measured: 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
Measured: 12 weeks
Concentration of insulin-like growth factor 1
Insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Oct 2024
- Primary completion24 Jul 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629805
- Sponsor's protocol ID
- 12-2024-003
- Status last verified
- Mar 2026
- First submitted
- 3 Oct 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aureobasidium Pullulans Produced β-glucan and Regular Combined Exercise on Musculoskeletal Function and Biomarkers in Adults With Relative Sarcopenia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06629805
- Acronym / sponsor ID
- 12-2024-003
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aureobasidium pullulans produced β-glucan group | Experimental | Dietary Supplement: Aureobasidium pullulans produced β-glucanThis group takes Aureobasidium pullulans produced β-glucan for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThis group takes placebo for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- <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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aureobasidium pullulans produced β-glucanAureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks | Dietary supplement | Aureobasidium pullulans produced β-glucan group |
| PlaceboPlacebo 1,000 mg/day for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
Muscle strength, 60°/s peak torque (%bodyweight)
Time frame: 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
Time frame: 12 weeks
Timed Up \& Go test
14 secondary outcomes
Appendicular skeletal mass/(height x height)
Time frame: 12 weeks
Appendicular skeletal mass/weight x 100
Time frame: 12 weeks
Skeletal Muscle Mass Index/(height x height)
Time frame: 12 weeks
Hand grip strength, both
Time frame: 12 weeks
Total body fat (%)
Time frame: 12 weeks
Truncal body fat (%)
Time frame: 12 weeks
Muscle power
Time frame: 12 weeks
Skeletal muscle mass (kg)
Time frame: 12 weeks
Short Physical Performance Battery total score
Time frame: 12 weeks
Gait speed (seconds)
Time frame: 12 weeks
Repeated chair stand test (seconds)
Time frame: 12 weeks
EuroQol five dimensional five levels
Time frame: 12 weeks
Concentration of insulin-like growth factor 1
Time frame: 12 weeks
Muscle strength, 60°/s peak torque
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aureobasidium pullulans produced β-glucan in people with Sarcopenia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength, 60°/s peak torque (%bodyweight) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.