Clinical trial NCT06629805: β-glucan and Exercise on Musculoskeletal Function in Sarcopenic Adults
Official title: Effect of Aureobasidium Pullulans Produced β-glucan and Regular Combined Exercise on Musculoskeletal Function and Biomarkers in Adults With Relative Sarcopenia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 116
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Aureobasidium pullulans produced β-glucan and regular combined exercise on muscle strength, muscle mass, muscle function, and biomarkers in adults with relative sarcopenia for 12 weeks.

Detailed description: A previous human study has indicated that Aureobasidium pullulans produced β-glucan may increase muscle mass and strength in the elderly. Therefore, the investigators will 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, expanding the target population to adults aged 50 and older 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 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
* Grip strength of the frequently used hand is based on the following age-specific standards: Men in their 50s (less than 42 kg, women: less than 25.1 kg), Men in their 60s (less than 38.5 kg, women: less than 24.1 kg), Men 70 and older (less than 33.2 kg, women: less than 20.9 kg)
* Individuals with a Short Physical Performance Battery score of 9 or higher.

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, and 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
measure: TUG test
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: Hand grip strength, both
timeFrame: 12 weeks
measure: Total body fat (%)
timeFrame: 12 weeks
measure: Truncal body fat (%)
timeFrame: 12 weeks
measure: Muscle power
timeFrame: 12 weeks
measure: Skeletal muscle mass (kg)
timeFrame: 12 weeks
measure: Short Physical Performance Battery total score
timeFrame: 12 weeks
measure: Gait speed (seconds)
timeFrame: 12 weeks
measure: Repeated chair stand test (seconds)
timeFrame: 12 weeks
measure: EuroQol five dimensional five levels
timeFrame: 12 weeks
measure: Concentration of insulin-like growth factor 1
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: