Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia

Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia: a Randomized Controlled Trial

The investigators 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 in adults with relative sarcopenia for 12 weeks.

Study Overview

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

Detailed Description

A previous study has indicated that Aureobasidium pullulans produced β-glucan may increase muscle mass and strength. Therefore, the investigators 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 in adults 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, as well as after 6 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): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (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
• Those who have an average protein intake of 60 g or more/day.

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, 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: Treatment
• 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 group; Placebo 300 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 group; 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
muscle strength	the peak torque at 60°/s knee extension (/kg)	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
concentration of creatinine kinase (IU/L)	creatinine kinase (IU/L) measured at baseline and after 12 weeks	12 weeks
concentration of lactate (mg/dL)	lactate (IU/L) measured at baseline and after 12 weeks	12 weeks
EuroQol five dimensional five levels	an 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 brain-derived neurotrophic factor	brain-derived neurotrophic factor (pg/mL) 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
Homeostatic Model Assessment for Insulin Resistance	Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist circumference	waist circumference (cm) measured at baseline and after 12 weeks	12 weeks
total cholesterol	total cholesterol (mg/dL) measured at baseline and after 12 weeks	12 weeks
Triglyceride	Triglyceride (mg/dL) measured at baseline and after 12 weeks	12 weeks
high-density lipoprotein cholesterol	high-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks	12 weeks
low-density lipoprotein cholesterol	low-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks	12 weeks
short physical performance battery	short physical performance battery (second) measured at baseline and after 12 weeks	12 weeks
Sit-up	Sit-up (count) measured at baseline and after 12 weeks	12 weeks
sit and reach	sit and reach (cm) measured at baseline and after 12 weeks	12 weeks
single leg stance	sit and reach (second) measured at baseline and after 12 weeks	12 weeks
6-min walk test	6-min walk test (meter) measured at baseline and after 12 weeks	12 weeks
400-meter walk test	400-meter walk test (second) measured at baseline and after 12 weeks	12 weeks
10-meter obstacle walk test	10-meter obstacle walk test (second) measured at baseline and after 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: October 23, 2021
• First Submitted That Met QC Criteria: October 23, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 2021-029-HR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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