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Table 1 Detailed study procedures

From: Evaluation of the effect of Lactobacillus reuteri V3401 on biomarkers of inflammation, cardiovascular risk and liver steatosis in obese adults with metabolic syndrome: a randomized clinical trial (PROSIR)

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