None listed
Conditions
Interventions
Dietary Supplement : Subjects selected based on the inclusion and exclusion criteria were randomly assigned to either the test group or the control group, and consumed one capsule (500 mg) of either D
Sponsors
Pusan National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged between 50 and 85 years at the time of screening who meet the inclusion criteria and do not meet any of the exclusion criteria. 2. Body Mass Index (BMI) between 18.5 and 30.0 kg/m², inclusive. 3. Skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) is less than 110% of the reference standard. 4.Handgrip strength in the dominant hand falls below the age- and sex-specific thresholds: -Males aged 50–59: = 42.0 kg; females: = 25.1 kg -Males aged 60–69: = 38.5 kg; females: = 24.1 kg -Males aged = 70: = 33.2 kg; females: = 20.9 kg 5.Short Physical Performance Battery (SPPB) score > 9 and does not meet any of the diagnostic criteria for sarcopenia, defined as: -Gait speed(less than 1.0 m/s), 400-meter walk time(more than 6 minutes), Five-chair stand test( more than 10 seconds), Timed Up and Go (TUG) test(more than 12 seconds) 6. Capable of performing normal daily physical activities and willing to voluntarily provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. History of fractures within the past 1 year. 2. Diagnosed with sarcopenia. 3. Patients with serious musculoskeletal abnormalities or injuries of the lower extremities that significantly impair walking, such as spinal stenosis requiring surgery. 4. Renal disease or serum creatinine level = 2 times the upper limit of the institutional reference range. 5. Uncontrolled liver disease or AST/ALT = 3 times the reference upper limit. 6. Uncontrolled diabetes mellitus (fasting blood glucose = 180 mg/dL). 7. Uncontrolled hyperthyroidism or hypothyroidism. 8. Uncontrolled hypertension or presence of cardiovascular diseases such as angina or myocardial infarction. 9. Taking psychiatric medications; however, intermittent use for sleep disorders is allowed. 10. History of cancer within the past 5 years or currently receiving treatment for cancer. 11. Individuals with dementia or Parkinson’s disease who are unable to communicate or walk independently. 12. History within the past 3 months of myocardial infarction, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), unstable angina, NYHA Class III or IV heart failure, severe valvular heart disease or defect, stroke, or untreated atrial fibrillation. 13. Use of oral steroids or corticosteroids, or intake of health supplements for muscle function within the past 4 weeks. 14. Currently taking or expected to continue taking medications or functional supplements that may affect the study results. 15. History of gastrointestinal resection (excluding appendectomy). 16. Pregnant or breastfeeding women. 17. Known hypersensitivity to the test product or its components. 18. Alcohol abuse. 19. Presence of asthma or restrictive/obstructive pulmonary disease that may affect lung volume. 20. Participation in regular aerobic or resistance exercise programs within the past 3 months. 21. Participation in another clinical trial within the past 3 months prior to the study. 22. Individuals who are likely to be noncompliant or deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in muscle strength, including: Quadriceps and hamstring strength (left and right sides) measured at an angular velocity of 60º/s using the Biodex system, and Handgrip strength measured using a hand grip dynamometer.;Change in Timed Up and Go (TUG) test results | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in muscle power measured at an angular velocity of 60°/s using the Biodex system;Change in skeletal muscle mass (SM) assessed by DEXA;Change in ASM index (ASM/height²) assessed using DEXA;Changes in total and trunk fat percentage assessed using DEXA;Change in ASM-to-weight ratio (%) assessed using DEXA;Change in height-adjusted Skeletal Muscle Mass Index (kg/m²), measured using DEXA;Changes in total and individual component scores of the Short Physical Performance Battery (SPPB);Changes in gait speed and the time to complete the five-repetition chair stand test, as part of the SPPB;Change in 400-meter walk time;Change in 6-minute walk distance;Changes in blood biomarkers, including serum creatine, total protein, albumin, prealbumin, CRP, CK, and myostatin;Changes in serum levels of inflammatory cytokines: IL-6, IL-1ß, IL-10, and TNF-a;EQ-5D-5L questionnaire;Changes in gut microbiota composition | — |
Countries
Korea, Republic of
Contacts
Public ContactMyung Jun Shin
Pusan National University Hospital
Outcome results
None listed