Clinical trial NCT05106686: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: muscle strength
timeFrame: 12 weeks
Secondary outcomes:
measure: appendicular skeletal mass/(height x height)
timeFrame: 12 weeks
measure: appendicular skeletal mass/weight x 100
timeFrame: 12 weeks
measure: skeletal Muscle Mass Index/(height x height)
timeFrame: 12 weeks
measure: concentration of creatinine kinase (IU/L)
timeFrame: 12 weeks
measure: concentration of lactate (mg/dL)
timeFrame: 12 weeks
measure: EuroQol five dimensional five levels
timeFrame: 12 weeks
measure: concentration of brain-derived neurotrophic factor
timeFrame: 12 weeks
measure: concentration of insulin-like growth factor 1
timeFrame: 12 weeks
measure: Homeostatic Model Assessment for Insulin Resistance
timeFrame: 12 weeks
Other outcomes:
measure: waist circumference
timeFrame: 12 weeks
measure: total cholesterol
timeFrame: 12 weeks
measure: Triglyceride
timeFrame: 12 weeks
measure: high-density lipoprotein cholesterol
timeFrame: 12 weeks
measure: low-density lipoprotein cholesterol
timeFrame: 12 weeks
measure: short physical performance battery
timeFrame: 12 weeks
measure: Sit-up
timeFrame: 12 weeks
measure: sit and reach
timeFrame: 12 weeks
measure: single leg stance
timeFrame: 12 weeks
measure: 6-min walk test
timeFrame: 12 weeks
measure: 400-meter walk test
timeFrame: 12 weeks
measure: 10-meter obstacle walk test
timeFrame: 12 weeks
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: