β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults

NCT06629805 | Completed

• 1 other identifier: 12-2024-003
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• Muscle strength

  The peak torque at 60°/s knee extension (/kg), right, left and the peak torque at 60°/s knee flexion (/kg), right, left

  12 weeks

• TUG test

  Timed Up \& Go test

  12 weeks

Secondary Outcomes (13)

• Appendicular skeletal mass/(height x height)

  12 weeks

• Appendicular skeletal mass/weight x 100

  12 weeks

• Skeletal Muscle Mass Index/(height x height)

  12 weeks

• Hand grip strength, both

  12 weeks

• Total body fat (%)

  12 weeks

Study Arms (2)

Aureobasidium pullulans produced β-glucan group

EXPERIMENTAL

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

Dietary Supplement: Aureobasidium pullulans produced β-glucan

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 12 weeks.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo 1,000 mg/day for 12 weeks

Placebo group

Aureobasidium pullulans produced β-glucan DIETARY_SUPPLEMENT

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

Aureobasidium pullulans produced β-glucan group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Sang Yeoup Lee, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: August 7, 2024
• Primary Completion: July 24, 2025
• Study Completion: December 31, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

KR (1)