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Completed

NCT Number: NCT06629805

β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aureobasidium pullulans produced β-glucan

Dietary Supplement

Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks

Placebo

Dietary Supplement

Placebo 1,000 mg/day for 12 weeks

Primary outcomes

  1. 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

  2. TUG test

    Time frame: 12 weeks

    Timed Up & Go test

Secondary outcomes

  1. Appendicular skeletal mass/(height x height)

    Time frame: 12 weeks

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

  2. Appendicular skeletal mass/weight x 100

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

  4. Hand grip strength, both

    Time frame: 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.

  5. Total body fat (%)

    Time frame: 12 weeks

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

  6. Truncal body fat (%)

    Time frame: 12 weeks

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

  7. Muscle power

    Time frame: 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

  8. Skeletal muscle mass (kg)

    Time frame: 12 weeks

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

  9. Short Physical Performance Battery total score

    Time frame: 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.

  10. Gait speed (seconds)

    Time frame: 12 weeks

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

  11. Repeated chair stand test (seconds)

    Time frame: 12 weeks

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

  12. EuroQol five dimensional five levels

    Time frame: 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

  13. Concentration of insulin-like growth factor 1

    Time frame: 12 weeks

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

  14. Muscle strength, 60°/s peak torque

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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