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Completed

NCT Number: NCT05106686

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aureobasidium pullulans produced β-glucan group

Dietary Supplement

Aureobasidium pullulans produced β-glucan 1,000 mg/day for 12 weeks

Placebo Group

Dietary Supplement

Placebo 300 mg/day for 12 weeks

Primary outcomes

  1. muscle strength

    Time frame: 12 weeks

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

Secondary outcomes

  1. appendicular skeletal mass/(height x height)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  2. appendicular skeletal mass/weight x 100

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  3. skeletal Muscle Mass Index/(height x height)

    Time frame: 12 weeks

    using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

  4. concentration of creatinine kinase (IU/L)

    Time frame: 12 weeks

    creatinine kinase (IU/L) measured at baseline and after 12 weeks

  5. concentration of lactate (mg/dL)

    Time frame: 12 weeks

    lactate (IU/L) measured at baseline and after 12 weeks

  6. EuroQol five dimensional five levels

    Time frame: 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

  7. concentration of brain-derived neurotrophic factor

    Time frame: 12 weeks

    brain-derived neurotrophic factor (pg/mL) measured at baseline and after 12 weeks

  8. concentration of insulin-like growth factor 1

    Time frame: 12 weeks

    insulin-like growth factor 1 (ng/mL) measured at baseline and after 12 weeks

  9. Homeostatic Model Assessment for Insulin Resistance

    Time frame: 12 weeks

    Homeostatic Model Assessment for Insulin Resistance measured at baseline and after 12 weeks

Other outcomes

  1. waist circumference

    Time frame: 12 weeks

    waist circumference (cm) measured at baseline and after 12 weeks

  2. total cholesterol

    Time frame: 12 weeks

    total cholesterol (mg/dL) measured at baseline and after 12 weeks

  3. Triglyceride

    Time frame: 12 weeks

    Triglyceride (mg/dL) measured at baseline and after 12 weeks

  4. high-density lipoprotein cholesterol

    Time frame: 12 weeks

    high-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks

  5. low-density lipoprotein cholesterol

    Time frame: 12 weeks

    low-density lipoprotein cholesterol (mg/dL) measured at baseline and after 12 weeks

  6. short physical performance battery

    Time frame: 12 weeks

    short physical performance battery (second) measured at baseline and after 12 weeks

  7. Sit-up

    Time frame: 12 weeks

    Sit-up (count) measured at baseline and after 12 weeks

  8. sit and reach

    Time frame: 12 weeks

    sit and reach (cm) measured at baseline and after 12 weeks

  9. single leg stance

    Time frame: 12 weeks

    sit and reach (second) measured at baseline and after 12 weeks

  10. 6-min walk test

    Time frame: 12 weeks

    6-min walk test (meter) measured at baseline and after 12 weeks

  11. 400-meter walk test

    Time frame: 12 weeks

    400-meter walk test (second) measured at baseline and after 12 weeks

  12. 10-meter obstacle walk test

    Time frame: 12 weeks

    10-meter obstacle walk test (second) measured at baseline and after 12 weeks

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2021
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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