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

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aureobasidium pullulans produced β-glucan group
placebo group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aureobasidium pullulans produced β-glucan group

Placebo group

Arm Description

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

This group takes placebo for 12 weeks.

Outcomes

Primary Outcome Measures

muscle strength
the peak torque at 60°/s knee extension (/kg)

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2021
Last Updated
April 29, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05106686
Brief Title
Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia
Official Title
Effect of Aureobasidium Pullulans Produced β-glucan on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aureobasidium pullulans produced β-glucan group
Arm Type
Experimental
Arm Description
This group takes Aureobasidium pullulans produced β-glucan for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Aureobasidium pullulans produced β-glucan group
Intervention Description
Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo group
Intervention Description
Placebo 300 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
muscle strength
Description
the peak torque at 60°/s knee extension (/kg)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
appendicular skeletal mass/(height x height)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
appendicular skeletal mass/weight x 100
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
skeletal Muscle Mass Index/(height x height)
Description
using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
concentration of creatinine kinase (IU/L)
Description
creatinine kinase (IU/L) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
concentration of lactate (mg/dL)
Description
lactate (IU/L) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
EuroQol five dimensional five levels
Description
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
Time Frame
12 weeks
Title
concentration of brain-derived neurotrophic factor
Description
brain-derived neurotrophic factor (pg/mL) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
concentration of insulin-like growth factor 1
Description
insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
Homeostatic Model Assessment for Insulin Resistance
Description
Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
waist circumference
Description
waist circumference (cm) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
total cholesterol
Description
total cholesterol (mg/dL) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
Triglyceride
Description
Triglyceride (mg/dL) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
high-density lipoprotein cholesterol
Description
high-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
low-density lipoprotein cholesterol
Description
low-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
short physical performance battery
Description
short physical performance battery (second) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
Sit-up
Description
Sit-up (count) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
sit and reach
Description
sit and reach (cm) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
single leg stance
Description
sit and reach (second) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
6-min walk test
Description
6-min walk test (meter) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
400-meter walk test
Description
400-meter walk test (second) measured at baseline and after 12 weeks
Time Frame
12 weeks
Title
10-meter obstacle walk test
Description
10-meter obstacle walk test (second) measured at baseline and after 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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