Table 1.
Detailed study procedures
| Visits (V) Week (W) |
V1 (W-2) |
V2 (W0) | V3 (W6) | V4 (W12) | Washout | V5 (W18) | V6 (W24) | V7 (W30) | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Screening analysis | X | |||||||||
| Demographics/ general information | X | |||||||||
| Informed content form | X | |||||||||
| Randomization and allocation | X | |||||||||
| Treatment distribution | X | |||||||||
| Blood test | X | X | X | X | ||||||
| Stools collection | X | X | X | X | X | X | ||||
| Hepatic ultrasound | X | X | X | |||||||
| Assessments | General outcomes | |||||||||
| Clinical interview | X | X | X | X | X | X | ||||
| Blood pressure and anthropometry | X | X | X | X | X | X | ||||
| 3-day dietary record | X | X | X | X | ||||||
| Food Frequency Questionnaire (FFQ) | X | X | X | X | ||||||
| Physical activity questionnaire (IPAQ) | X | X | X | X | ||||||
| Primary outcomes | ||||||||||
| Plasma LPS | X | X | X | X | ||||||
| Secondary outcomes | ||||||||||
| Blood Pressure | X | X | X | X | X | X | ||||
| HOMA | X | X | X | X | ||||||
| Lipid profile | X | X | X | X | ||||||
| Inflammatory markers | X | X | X | X | ||||||
| Hepatic steatosis markers | X | X | X | X |