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CompletedNCT06629805Updated Jul 28, 2026

β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults

An interventional study of Aureobasidium pullulans produced β-glucan and Placebo in Sarcopenia, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in South Korea. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 116 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
116 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo group

    This group takes placebo for 12 weeks.

    Dietary Supplement: Placebo

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 weeks

  2. TUG test

    Timed Up \& Go test

    Time frame: 12 weeks

Secondary outcomes

  1. Appendicular skeletal mass/(height x height)

    Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

    Time frame: 12 weeks

  2. Appendicular skeletal mass/weight x 100

    Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

    Time frame: 12 weeks

  3. Skeletal Muscle Mass Index/(height x height)

    Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

    Time frame: 12 weeks

  4. 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.

    Time frame: 12 weeks

  5. Total body fat (%)

    Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

    Time frame: 12 weeks

  6. Truncal body fat (%)

    Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

    Time frame: 12 weeks

  7. 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

    Time frame: 12 weeks

  8. Skeletal muscle mass (kg)

    Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

    Time frame: 12 weeks

  9. 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.

    Time frame: 12 weeks

  10. Gait speed (seconds)

    Assessed by timing the participants as they walked 2.44 metres at their regular pace at baseline and after 12 weeks

    Time frame: 12 weeks

  11. Repeated chair stand test (seconds)

    Timed as they completed five sit-to-stand repetitions at baseline and after 12 weeks

    Time frame: 12 weeks

  12. 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

    Time frame: 12 weeks

  13. Concentration of insulin-like growth factor 1

    Insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks

    Time frame: 12 weeks

  14. 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

    Time frame: 12 weeks

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, 50612, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06629805
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Sang Yeoup Lee (Professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Oct 8, 2024
Start date
Oct 4, 2024
Primary completion
Jul 24, 2025
Completion
Dec 31, 2025
Last update
Jul 28, 2026

Study contacts

Sang Yeoup Lee, MD, PhD
principal investigator · Pusan National University Yangsan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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