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 |