NCT05106686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 23, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

October 23, 2021

Last Update Submit

April 29, 2023

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • muscle strength

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

    12 weeks

Secondary Outcomes (9)

  • appendicular skeletal mass/(height x height)

    12 weeks

  • appendicular skeletal mass/weight x 100

    12 weeks

  • skeletal Muscle Mass Index/(height x height)

    12 weeks

  • concentration of creatinine kinase (IU/L)

    12 weeks

  • concentration of lactate (mg/dL)

    12 weeks

  • +4 more secondary outcomes

Other Outcomes (12)

  • waist circumference

    12 weeks

  • total cholesterol

    12 weeks

  • Triglyceride

    12 weeks

  • +9 more other outcomes

Study Arms (2)

Aureobasidium pullulans produced β-glucan group

EXPERIMENTAL

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

Dietary Supplement: Aureobasidium pullulans produced β-glucan group

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 12 weeks.

Dietary Supplement: placebo group

Interventions

Aureobasidium pullulans produced β-glucan groupDIETARY_SUPPLEMENT

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

Aureobasidium pullulans produced β-glucan group
placebo groupDIETARY_SUPPLEMENT

Placebo 300 mg/day for 12 weeks

Placebo group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Sang Yeoup Lee, MD, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2021

First Posted

November 4, 2021

Study Start

September 10, 2021

Primary Completion

May 30, 2022

Study Completion

May 31, 2022

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)