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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106686
• Other study ID #: 2021-029-HR
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2023
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 31, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Aureobasidium pullulans produced ß-glucan group
Aureobasidium pullulans produced ß-glucan 1,000 mg/day for 12 weeks
• placebo group
Placebo 300 mg/day for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	waist circumference	waist circumference (cm) measured at baseline and after 12 weeks	12 weeks
Other	total cholesterol	total cholesterol (mg/dL) measured at baseline and after 12 weeks	12 weeks
Other	Triglyceride	Triglyceride (mg/dL) measured at baseline and after 12 weeks	12 weeks
Other	high-density lipoprotein cholesterol	high-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks	12 weeks
Other	low-density lipoprotein cholesterol	low-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks	12 weeks
Other	short physical performance battery	short physical performance battery (second) measured at baseline and after 12 weeks	12 weeks
Other	Sit-up	Sit-up (count) measured at baseline and after 12 weeks	12 weeks
Other	sit and reach	sit and reach (cm) measured at baseline and after 12 weeks	12 weeks
Other	single leg stance	sit and reach (second) measured at baseline and after 12 weeks	12 weeks
Other	6-min walk test	6-min walk test (meter) measured at baseline and after 12 weeks	12 weeks
Other	400-meter walk test	400-meter walk test (second) measured at baseline and after 12 weeks	12 weeks
Other	10-meter obstacle walk test	10-meter obstacle walk test (second) measured at baseline and after 12 weeks	12 weeks
Primary	muscle strength	the peak torque at 60°/s knee extension (/kg)	12 weeks
Secondary	appendicular skeletal mass/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	appendicular skeletal mass/weight x 100	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	skeletal Muscle Mass Index/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	concentration of creatinine kinase (IU/L)	creatinine kinase (IU/L) measured at baseline and after 12 weeks	12 weeks
Secondary	concentration of lactate (mg/dL)	lactate (IU/L) measured at baseline and after 12 weeks	12 weeks
Secondary	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
Secondary	concentration of brain-derived neurotrophic factor	brain-derived neurotrophic factor (pg/mL) measured at baseline and after 12 weeks	12 weeks
Secondary	concentration of insulin-like growth factor 1	insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks	12 weeks
Secondary	Homeostatic Model Assessment for Insulin Resistance	Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks	12 weeks