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Efficacy and safety of GS8210213 on muscle function

12 weeks, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of GS8210213 on muscle function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010190
Enrollment
100
Registered
2025-02-13
Start date
2022-10-20
Completion date
Unknown
Last updated
2025-03-03

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 : Experimental: GS8210213(1,000mg/day), 12 weeks, twice a day, 2 capsule at a time Control: Placebo (test object with no GS8210213 and same properties as test), 12 weeks, twice a

Sponsors

Univera
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females aged 50 years over at the screening examination 2) Those with a total score of 13 or less on SARC-CalF 3) Those whose skeletal muscle mass measured by BIA Bioelectrical Impedance Analysis) is less than 100% of the standard 4)Individuals who have fully understood the detailed explanation of this human study, voluntarily decided to participate, and provided written consent to comply with the guidelines

Exclusion criteria

Exclusion criteria: 1) Patients with a clinically significant disease requiring treatment (i.e., severe cardiovascular system, endocrine system, neuropsychiatric system, musculoskeletal inflammation, gastrointestinal disease, inflammatory disease, blood and tumor disease, etc.) 2) Patients who take medicine or health functional food for myofunction within a month prior to the screening examination 3) Patients with a history of antipsychotic medication use within 2 months prior to the screening examination 4)Patients who have participated in other clinical trials within 3 months prior to the screening examination 5)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Design outcomes

Primary

MeasureTime frame
Isokinetic muscular strength;Handgrip Strength;Muscle mass;Short Physical Performance; SPPB

Secondary

MeasureTime frame
composite score;Muscle-related hormones;Timed up and go; TUG;C-Reactive Protein;skeletal muscle index; SMI

Countries

Korea, Republic of

Contacts

Public Contactsi yeon Lee

Jeonbuk National University Hospital

sylee@jbctc.org+82-63-259-3052

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026