None listed
Conditions
Interventions
Others(Health Functional Food) : Subjects in the treatment group received the investigational product (HY7715), two capsules once daily after breakfast for 12 weeks.
Subjects in the placebo group rece
Sponsors
Hy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects aged 50 to 85 years. 2) Subjects with handgrip strength in both hands below the age- and sex-specific reference values according to the 2022 Korea National Health Statistics: ? Aged 50–59 years: =42 kg for men, =25.1 kg for women ? Aged 60–69 years: =38.5 kg for men, =24.1 kg for women ? Aged 70–85 years: =33.2 kg for men, =20.9 kg for women 3) Subjects with a Short Physical Performance Battery (SPPB) score greater than 9. 4) Subjects who voluntarily agreed to participate in this study and provided written informed consent prior to the start of the study.
Exclusion criteria
Exclusion criteria: 1) Subjects currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatobiliary, renal and urinary, neurological, psychiatric, infectious diseases, or malignant tumors (except for non-melanoma skin tumors and subjects who have been disease-free for at least 5 years after cancer treatment). 2) Subjects who are considered unable to perform exercise due to musculoskeletal disorders, neurological disorders, or cognitive impairment (including those with spinal conditions causing significant limitations in walking requiring surgery). 3) Subjects with fragility hip fractures. 4) Subjects with gastrointestinal disorders that may interfere with the intake of the investigational product. 5) Subjects diagnosed with severe psychiatric disorders such as schizophrenia, bipolar I disorder, or recurrent major depressive disorder and currently under treatment (subjects with well-controlled mild depression may be included at the investigator’s discretion). 6) Subjects who have taken antipsychotics within 8 weeks prior to Visit 1 (subjects taking sleep medications for treatment of sleep disorders may be included). 7) Subjects with handgrip strength less than 28 kg for men and less than 18 kg for women. 8) Subjects diagnosed with sarcopenia. 9) Subjects with a body mass index (BMI) =30 kg/m². 10) Subjects who have received systemic corticosteroids (e.g., cortisol) or hormone therapy (e.g., testosterone, estrogen, androgen, growth-related hormones, or adrenal cortical hormones) within 4 weeks prior to Visit 1. 11) Subjects who have taken supplements related to muscle improvement (e.g., amino acids, creatine) or health functional foods (including calcium and vitamin D) within 2 weeks prior to Visit 1 (subjects may be included if calcium or vitamin D has been taken without dose changes for at least 3 months). 12) Subjects who have taken medications that may affect muscle (e.g., muscle relaxants, calcium supplements) within 1 week prior to Visit 1 (subjects may be included if calcium supplements have been taken without dose changes for at least 3 months). 13) Subjects who have received non-pharmacological treatments that may affect muscle within 1 week prior to Visit 1. 14) Subjects who have received antibiotics within 2 weeks prior to Visit 1. 15) Subjects who have taken gastrointestinal regulators, probiotics, prebiotics, or lactic acid bacteria products within 3 weeks prior to Visit 1. 16) Subjects with a history of alcohol abuse or chronic alcohol consumption*. *Defined as an average daily intake of =40 g (=280 g/week) for men and =20 g (=140 g/week) for women. 17) Heavy smokers (=20 cigarettes per day). 18) Subjects who have participated in resistance exercise regularly (=3 times per week) within 3 months prior to Visit 1. 19) Subjects with eGFR <60 mL/min/1.73m². 20) Subjects with AST (GOT) or ALT (GPT) =3 times the upper limit of normal at the study site. 21) Subjects with uncontrolled hypertension (systolic blood pressure =150 mmHg or diastolic blood pressure =90 mmHg after at least 10 minutes of rest). 22) Subjects with uncontrolled diabetes (fasting blood glucose =180 mg/dL). 23) Subjects with TSH =0.1 µIU/mL or =10 µIU/mL. 24) Pregnant or lactating women, or subjects planning pregnancy during the study period. 25) Subjects who have participated in another interventional clinical trial (including human studies) within 3 months prior to Visit 1 or plan to participate in another interventional clinical trial dur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quadriceps muscle strength;handgrip strength;Short Physical Performance Battery (SPPB) | — |
Secondary
| Measure | Time frame |
|---|---|
| muscle power;Appendicular Skeletal Muscle Mass/Height²;Appendicular Skeletal Muscle Mass/Weight × 100;Skeletal Muscle Mass;body fat percentage;Timed Up and Go test;EuroQol-five-dimensions three-level version;blood biomarkers;hamstring muscle strength | — |
Countries
Korea, Republic of
Contacts
Public ContactDon Kyu Kim
Chung-Ang University Gwangmyeong Hospital
Outcome results
None listed