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

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: placebo group; Dietary Supplement: Aureobasidium pullulans produced β-glucan group

• Registration Number: NCT05106686
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2021-09-10
• Study First Submitted: 2021-10-23
• Study First Submitted QC: 2021-10-23
• Study First Posted: 2021-11-04
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-29
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo group	This group takes placebo for 12 weeks.
Aureobasidium pullulans produced β-glucan group	Aureobasidium pullulans produced β-glucan group	This group takes Aureobasidium pullulans produced β-glucan for 12 weeks.

Primary Outcome Measures

Name	Time	Method
muscle strength	12 weeks	the peak torque at 60°/s knee extension (/kg)

Secondary Outcome Measures

Name	Time	Method
appendicular skeletal mass/(height x height)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
appendicular skeletal mass/weight x 100	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
skeletal Muscle Mass Index/(height x height)	12 weeks	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
concentration of creatinine kinase (IU/L)	12 weeks	creatinine kinase (IU/L) measured at baseline and after 12 weeks
concentration of lactate (mg/dL)	12 weeks	lactate (IU/L) measured at baseline and after 12 weeks
EuroQol five dimensional five levels	12 weeks	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
concentration of brain-derived neurotrophic factor	12 weeks	brain-derived neurotrophic factor (pg/mL) measured at baseline and after 12 weeks
concentration of insulin-like growth factor 1	12 weeks	insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks
Homeostatic Model Assessment for Insulin Resistance	12 weeks	Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of