Table 1.
Clinical trial schedule.
| Assessment | Screening | Ingestion period | Out of schedule visit | |||
|---|---|---|---|---|---|---|
| D-14~D-1 | D0 (0wk, Baseline) | D42 ± 7 (6wk) | D84 ± 7 (12wk) | |||
| Subject consent | ○ | |||||
| Screening numbering | ○ | |||||
| Demographics questionnaire | ○ | |||||
| Body measurement | ○ | ○ | ○ | ○ | (○) | |
| Lifestyle questionnaire | ○ | ○ | (○) | |||
| Vital signs | ○ | ○ | ○ | ○ | ○ | |
| Medical history and comorbidity | ○ | ○ | ||||
| Physical test | ○ | ○ | ○ | ○ | ○ | |
| Medication investigation | ○ | ○ | ○ | ○ | ○ | |
| Laboratory test | ○ | ○ | (○) | |||
| Pregnancy test (for women of childbearing potential) | ○ | ○ | (○) | |||
| Subject suitability assessment | ○ | |||||
| Randomization | ○ | |||||
| IPAQ | ○ | ○ | (○) | |||
| Dietary Questionnaire (24 h recall) | ○ | ○ | (○) | |||
| Functional test | DXA | ○ | ○ | (○) | ||
| Muscle strength (Hand grip) | ○ | ○ | ○ | ○ | (○) | |
| SPPB | ○ | ○ | ○ | (○) | ||
| TNF-α, IL-6, IGF-1 | ○ | ○ | (○) | |||
| Product prescription | ○ | ○ | ||||
| Adverse event | ○ | ○ | ○ | |||
| Adherence assessment | ○ | ○ | (○) | |||
DXA = dual-energy X-ray absorptiometry, IGF-1 = insulin-like growth factor-1, IL-6 = interleukin-6, IPAQ = International Physical Activity Questionnaire, SPPB = short physical performance battery, TNF-α = tumor necrosis factor-α.