β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults

NCT ID: NCT06629805

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-07
• Study Completion Date: 2025-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Aureobasidium pullulans produced β-glucan group

This group takes Aureobasidium pullulans produced β-glucan for 12 weeks.

Group Type: EXPERIMENTAL

Aureobasidium pullulans produced β-glucan

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

This group takes placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo 1,000 mg/day for 12 weeks

Interventions

Aureobasidium pullulans produced β-glucan

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo 1,000 mg/day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

12-2024-003

Identifier Type: -

Identifier Source: org_study_id