Table 1.
Schedule for data collection, treatments, and outcome measurements
| Period | S | T | F | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Week | 0 | 1a | 1 | 2 | 2 | 3 | 3 | 4 | 4 | 5 | 5 | 6 | 6b | 7c |
| Eligibility test | ○ | |||||||||||||
| Informed consent | ○ | |||||||||||||
| Demographic characteristics | ○ | |||||||||||||
| Random allocation | ○ | |||||||||||||
| Treatment | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ||
| Serum metabolites | ○ | ○ | ||||||||||||
| BIA | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |||||||
| WC/HC | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |||||||
| IPAQ | ○ | ○ | ||||||||||||
| SRRS | ○ | ○ | ||||||||||||
| SRI | ○ | ○ | ||||||||||||
| FSS | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |||||||
| BDI | ○ | ○ | ||||||||||||
| Urine metabolites | ○ | ○ | ||||||||||||
| Adverse events | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
| Credibility test | ○ | |||||||||||||
S screening period, T treatment period, F follow-up period, BIA bioelectrical impedance analysis, WC waist circumference, HC hip circumference, IPAQ International Physical Activity Questionnaire, SRRS Social Readjustment Rating Scale, SRI Stress Response Inventory, FSS Fatigue Severity Scale, BDI Beck’s Depression Inventory
a Baseline (immediately before the first treatment); b end of 6-week treatment; c endpoint (within 3 days after completion of the 6-week treatment)