None listed
Conditions
Interventions
Others : Experimental(Dr-UE50): Take one capsule twice daily, approximately 30 minutes after meals, with plenty of water (containing 340 mg of slippery elm extract powder per capsule). Administer oral
Sponsors
Dr.Oregonin Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) persons aged 50 or older and 85 or younger 2) A person whose grip strength measurement of both hands falls below the age standard (National Health Statistics, 2022) ? 50 years old and 59 years old or less: 42 kg or less for men and 25.1 kg or less for women ? 60 years old or older, 69 years old or younger: 38.5 kg or less for men and 24.1 kg or less for women ? 70 years old or older, 85 years old or younger: 33.2 kg or less for men and 20.9 kg or less for women 3) A person whose simple physical performance evaluation (SPPB) exceeds 9 points 4)A person who has agreed to participate in the human body application test before the commencement of the human body application test and has prepared an Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/liver and biliary system, kidney and urinary system, infectious disease and malignant tumors (except for skin tumors other than melanoma, those who have been cured of cancer can participate in the treatment) 2) Those with serious lower limb musculoskeletal abnormalities or damage (those who have restricted walking to the extent that surgery is required due to spinal diseases such as spinal stenosis) 3) Those who cannot talk or walk due to dementia or Parkinson's disease (mild symptoms can participate) 4) a person with a fragile hip fracture 5) A person who has a problem with eating food for human application test due to gastrointestinal disorders 6) A person who is taking drugs in neuropsychiatry due to psychiatric disorders (but depression that is intermittently administered or properly treated due to sleep disorders may participate in the examiner's judgment) 7) A person whose grip strength is less than 28 kg for men and less than 18 kg for women 8) a person diagnosed with sarcopenia 9) Those with a BMI of 30 kg/m2 or higher10) Systemic steroid preparations (cortisol, etc.) or hormone preparations (testosterone, estrogen, androgen, growth-related hormones, adrenocortical hormones, etc.) within 4 weeks of visit 1 (but statin preparations can be participated if they are being taken without change of dose for at least 6 months 11) Those who have used muscle strength improvement-related supplements (amino acids, creatines, etc.) or muscle strength improvement-related health functional foods (including calcium and vitamin D) within 2 weeks of visit 1 (but calcium and vitamin D can be participated if they have been administered without change of dose since 3 months ago) 12) A person who has taken drugs (muscle relaxants, calcium supplements, etc.) that may affect his or her muscles or received non-drug treatment within one week on the basis of visit 1 13) A person who has a history of alcohol abuse or is chronically consuming alcohol *Drinks alcohol equivalent to an average of 40 g or more (280 g/week) per day for men and 20 g or more (140 g/week) per day for women 14) Excessive smokers (20 or more per day) 15)A person who has participated in resistance exercises continuously (more than 3 days a week) within 3 months on the basis of visit 1 16) A person with an eGFR of less than 60 mL/min/1.73 m2 17) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 18) Uncontrolled hypertension patients (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg, and measurement criteria after stabilizing for 10 minutes in the test subjects) 19) Uncontrolled Diabetes Patients (HbA1c > 7.0%) 20) Those whose TSH is less than or equal to 0.1 µIU/mL or greater than or equal to 10 µIU/Ml 21) A person who is pregnant or is lactating or has a pregnancy plan during the main human body application test period 22) A person who has participated in other interventional clinical trials (including human-applied trials) within three months of the visit 1 or who plans to participate in other interventional clinical trials (including human-applied trials) during this human-applied trial period 23) A person who is sensitive to or allergic to the ingredients of food (test and control foods) for this human application test 24) A person who deems that the tester is u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change amount and rate of change in femoral muscle strength | — |
Secondary
| Measure | Time frame |
|---|---|
| Change amount and rate of change in femoral muscle strength;Change amount and rate of change of change in grip strength;Change amount and rate of change of SPPB;Change amount and rate of change of ASM/Height2;Change amount and rate of change of ASM/Weight;Change amount and rate of change of SMM;Change amount and rate of change in MFR, BMC, Fat (Arms, Trunk, Legs, Subtotal, Head, Android, Gynoid);Change amount and rate of change of EQ- 5D-3L;Change amount and rate of change in blood indicators(GPx, IL-1ß, IGF-1);Blood lipids(Total Cholesterol, HDL- Cholesterol, LDL-Cholesterol, Triglyceride), Glucose;Adverse Event;Clinical pathology test (hematological/blood chemical test, urine test);Vital signs (blood pressure, pulse), physical measurements (weight, BMI);electrocardiogram test | — |
Countries
Korea, Republic of
Contacts
Public ContactJunyoung Park
Yonsei University Yongin Severance Hospital
Outcome results
None listed