Prebiotic fibre represents a promising and efficacious treatment to manage pre-diabetes, acting via complementary pathways involving the gut microbiome and viscosity-related properties. In this study, we evaluated the effect of using a diverse prebiotic fibre supplement on glycaemic, lipid and inflammatory biomarkers in patients with pre-diabetes. Sixty-six patients diagnosed with pre-diabetes (yet not receiving glucose-lowering medications) were randomised into treatment (thirty-three) and placebo (thirty-three) interventions. Participants in the treatment arm consumed 20 g/d of a diverse prebiotic fibre supplement, and participants in the placebo arm consumed 2 g/d of cellulose for 24 weeks. A total of fifty-one and forty-eight participants completed the week 16 and week 24 visits, respectively. The intervention was well tolerated, with a high average adherence rate across groups. Our results extend upon previous work, showing a significant change in glycated haemoglobin (HbA1c) in the treatment group but only in participants with lower baseline HbA1c levels (< 6 % HbA1c) (P = 0·05; treatment –0·17 ± 0·27 v. placebo 0·07 ± 0·29, mean ± sd). Within the whole cohort, we showed significant improvements in insulin sensitivity (P = 0·03; treatment 1·62 ± 5·79 v. placebo –0·77 ± 2·11) and C-reactive protein (PFWE = 0·03; treatment –2·02 ± 6·42 v. placebo 0·94 ± 2·28) in the treatment group compared with the placebo. Together, our results support the use of a diverse prebiotic fibre supplement for physiologically relevant biomarkers in pre-diabetes.

We have analysed the trial results obtained in two placebo and imipramine controlled double blind studies with a new psychotropic compound. Statistical analysis as outlined in the protocol showed a rather meagre therapeutic effect of imipramine of 1.53 points difference on HAMD-17 total score in comparison to placebo. In order to increase the discriminative power of the analysis we performed a post hoc analysis selecting centres that were able to detect a difference of at least two centres points between imipramine and placebo on HAMD-17 total score at week 6 (selective centres). All other were called nonselective. The analysis revealed that there were no statistically significant differences between the two types of centres concerning patient characteristics except that the nonselective centres recruited less patients with previous good response to antidepressant treatment. There was also some difference in drop out rates in the active treatment group wich might indicate different treatment strategies in the two groups of centres that participated in this trials.