β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Aureobasidium pullulans produced β-glucan; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Yangsan, South Korea, 50612
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; This group takes placebo for 12 weeks.	Dietary supplement: Placebo; Placebo 1,000 mg/day for 12 weeks
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; Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TUG test	Timed Up & Go test	12 weeks
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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appendicular skeletal mass/(height x height)	Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Appendicular skeletal mass/weight x 100	Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Skeletal Muscle Mass Index/(height x height)	Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	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.	12 weeks
Total body fat (%)	Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Truncal body fat (%)	Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	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	12 weeks
Skeletal muscle mass (kg)	Using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	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.	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	12 weeks
Repeated chair stand test (seconds)	Timed as they completed five sit-to-stand repetitions at baseline and after 12 weeks	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	12 weeks
Concentration of insulin-like growth factor 1	Insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks	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	12 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): July 24, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: 12-2024-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No