3.3 Body composition Product effect on the changes in body weight and BMI from V2 to V5 was close to significance level (in the ITT and the PP populations for body weight, in the PP population for BMI; p < 0.1): body weight and BMI tended to increase in the placebo arm, while remaining relatively stable in the scFOS arm ( Table 3 ).
Regarding total SCFAs, the level tended to increase with scFOS supplementation and to decrease with placebo (mean change: +24.6 vs −32.2 μmol/g in the ITT population), although the treatment effect did not reach statistical significance ( p = 0.1234 in the ITT population; p = 0.0886 in the PP population). 3.5 Safety While the overall prevalence of adverse events in this study was relatively high (77.3% of subjects; 67.7% in the placebo arm, 85.7% in the scFOS arm), most were expected gastrointestinal symptoms consistent with the known safety profile of the investigational product scFOS.