None listed
Conditions
Interventions
Others(Health functional food) : The investigational product (FA) or placebo was administered once daily, one sachet per dose, after breakfast.
Sponsors
Hy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged =50 and =85 years (based on full years of age). 2) Males with handgrip strength less than 36 kg and females with handgrip strength less than 22 kg. 3) Participants whose skeletal muscle mass measured by InBody is below 100% of the standard reference value. 4) Participants who have agreed to participate in this clinical trial prior to its initiation and have signed the written Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) Participants currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal/urinary, neurological, psychiatric, infectious diseases, or malignant tumors. 2) Participants judged unable to perform exercise due to musculoskeletal or neurological disorders, or cognitive impairment. 3) Participants with fragility hip fractures. 4) Participants with a BMI =30 kg/m². 5) Participants who received systemic steroid therapy (e.g., cortisol) or hormonal therapy (e.g., testosterone, estrogen, growth-related hormones, adrenocortical hormones) within 4 weeks prior to Visit 1. 6) Participants who used muscle strength–related supplements (e.g., amino acids, creatine) or health functional foods (including vitamin D) within 2 weeks prior to Visit 1 (exception: participants continuously taking vitamin D at a stable dose for more than 3 months are eligible). 7) Participants who regularly consume more than 140 g of alcohol per week (approximately 2.5 bottles of soju per week, ~2.5 glasses per day). 8) Participants who have engaged in sustained aerobic or resistance exercise at least 3 times per week within 3 months prior to Visit 1. 9) Participants with serum creatinine >2.0 mg/dL. 10) Participants with AST (GOT) or ALT (GPT) levels =3 times the upper limit of normal at the study site. 11) Participants with uncontrolled hypertension (systolic BP =160 mmHg or diastolic BP =100 mmHg, measured after 10 minutes of rest). 12) Participants with uncontrolled diabetes (fasting glucose =180 mg/dL). 13) Participants with TSH =0.1 µIU/mL or =10 µIU/mL. 14) Pregnant or breastfeeding participants, or those planning pregnancy during the study period. 15) Participants who have participated in other interventional clinical trials (including human clinical trials) within 3 months prior to Visit 1, or who plan to participate in another interventional clinical trial during this study. 16) Participants with hypersensitivity or allergy to any component of the investigational product. 17) Participants deemed unsuitable by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quadriceps muscle strength | — |
Secondary
| Measure | Time frame |
|---|---|
| Handgrip strength;Appendicular Skeletal Muscle Mass/Height^2;Appendicular Skeletal Muscle Mass/Weight?100;Skeletal muscle mass(Dual Energy X-ray Absorptiometry);Body fat percentage;Short Physical Performance Battery(SPPB);Blood biomarkers (Creatine Kinase, Lactate Dehydrogenase, Aspartate Aminotransferase(Glutamic Oxaloacetic Transaminase), Alanine Aminotransferase(Glutamic Pyruvic Transaminase), Blood Urea Nitrogen, Creatinine, C-Reactive Protein);Cytokine(TNF-a, IL-1ß, IL-6);Glutathione;Superoxide Dismutase | — |
Countries
Korea, Republic of
Contacts
Public ContactDon-kyu Kim
Chung-Ang University Gwangmyeong Hospital
Outcome results
None listed