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A clinical study to evaluate the efficacy and safety of 2'-FL on Muscular Function.

A 12-Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of 2'-FL on Muscular Function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010723
Enrollment
120
Registered
2025-07-07
Start date
2023-03-13
Completion date
Unknown
Last updated
2025-11-17

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 Groups: - Low-Dose 2'-FL Group: Take one sachet daily before meals.(equivalent to 2.0 g 2’-FL/day). - High-Dose 2'-FL Group: Take one sachet daily before meals. (equi

Sponsors

Advanced Protein Technologies Corp.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male or female subjects aged between 50 and 74 years, inclusive. 2) Individuals with skeletal muscle mass at or below 110% of the standard value, as measured by Bioelectrical Impedance Analysis (BIA). 3) Individuals whose grip strength measures between 28.0kg and 39.0kg for males, and between 18.0kg and 24.0kg for females. 4) Individuals who have received a detailed explanation of the study, fully understood the information provided, voluntarily agreed to participate, and provided written informed consent to comply with all study-related instructions during the trial period.

Exclusion criteria

Exclusion criteria: 1) Individuals with a BMI of 18.5 kg/m2 or less, or 30 kg/m2 or more. 2) Individuals with a weight change of 5% or more within 1 month of the screening. 3) Individuals with musculoskeletal disorders that currently make exercise difficult. 4) Individuals in high-intensity occupational activity groups or those who repeatedly perform high-intensity exercise for muscle strengthening purposes more than 3 times a week. 5) Individuals with gait disturbances or those who use or wear walking aids. 6) Individuals taking medications or health functional foods related to muscle function and strength improvement. 7) Individuals who have continuously consumed dietary supplements and functional foods for the purpose of muscle strength improvement and muscle mass increase. 8) Individuals who have continuously administered steroid drugs for the purpose of treating inflammation and pain. 9) Individuals who have continuously consumed dietary supplements, beverages, or drugs containing AAS (anabolic steroid) agents. 10) Individuals diagnosed with diabetes or patients with uncontrolled hypertension. 11) Individuals with a history of antipsychotic drug treatment. 12) Individuals with clinically significant severe cardiovascular, cerebrovascular, endocrine, neuropsychiatric, musculoskeletal, gastrointestinal, inflammatory, and hematologic/oncologic diseases requiring treatment. 13) Individuals with or suspected of having alcohol addiction or drug abuse. 14) Individuals who have participated in another human application test within 3 months prior to the screening test. 15) Individuals showing the following results in diagnostic laboratory tests: - AST, ALT > 3 times the upper limit of the reference range - Serum Creatinine > 2.0 mg/dl 16) Individuals who are deemed unsuitable for study participation by the principal investigator due to diagnostic laboratory test results or other reasons.

Design outcomes

Primary

MeasureTime frame
isokinetic test

Secondary

MeasureTime frame
SPPB; Short Physical Performance Battery;Timed up and go;Total Lean Mass;Appendicular lean mass index (ALMI);Myostatin

Countries

Korea, Republic of

Contacts

Public ContactTaeuk Kim

Dankook Univeristy Hospital

magnarbor@dankook.ac.kr+82-41-550-7494

Outcome results

None listed

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