Human trial to evaluate the efficacy and safety of HB05P on muscle function

A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of HB05P on muscle function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009883

Enrollment

100

Registered

2024-10-25

Start date

2022-05-31

Completion date

Unknown

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : -HB05P • Main Component: HB05P 50 mg/Capsule • Weight: 430mg/Capsule • Usage and Capacity: Intake 1 Capsule/Once a day • Intake period: 12-weeks - Placebo • Main Component: crys

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 60 years or older at the time of screening. 2) Individuals with a total score of less than 11 on the Sarcopenia Screening Questionnaire (SARC-CalF). 3) Individuals who, after receiving and fully understanding a detailed explanation of the clinical trial, voluntarily agree to participate and comply with the instructions by providing written consent.

Exclusion criteria

Exclusion criteria: 1) Individuals who have continuously consumed probiotic products (or probiotic supplements) and fermented dairy products (such as yogurt, cheese, etc.) at least 4 times per week within 2 weeks prior to screening. 2) Individuals with a BMI of 30 kg/m² or higher. 3) Individuals with clinically significant severe cardiovascular, endocrine, neurological, musculoskeletal, gastrointestinal, inflammatory, or hematologic/oncological diseases requiring treatment. 4) Individuals who have taken medications or health supplements related to muscle function within 1 month prior to screening (refer to the list of prohibited concomitant medications). 5) Individuals who have received antipsychotic medication treatment within 2 months prior to screening. 6) Individuals with or suspected of having alcohol addiction or drug abuse. 7) Individuals who have participated in another clinical trial within 3 months prior to screening. 8) Individuals showing the following results in diagnostic laboratory tests: -AST or ALT levels greater than 3 times the upper limit of the reference range -Serum Creatinine > 2.0 mg/dl 9) Individuals deemed unsuitable for the study by the principal investigator due to diagnostic laboratory test results or other reasons.

Design outcomes

Secondary

Measure	Time frame
Grip Strength;muscle mass;gait speed;Relative skeletal muscle mass index (RSMI);Timed up and go (TUG);Follistatin, Myostatin	—

Primary

Measure	Time frame
Isokinetic muscle strength	—

Countries

Korea, Republic of

Contacts

Public ContactEun-Soo Jung

Jeonbuk National University Hospital

esjung@jbctc.org+82-63-259-3049

Outcome results