A microbiome‐targeting fibre‐enriched nutritional formula is well tolerated and improves quality of life and haemoglobin A1c in type 2 diabetes: A double‐blind, randomized, placebo‐controlled trial

Abstract Aims To investigate a prebiotic fibre‐enriched nutritional formula on health‐related quality of life and metabolic control in type 2 diabetes. Materials and Methods This was a 12‐week, double‐blind, placebo‐controlled study with an unblinded dietary advice only comparator arm. Participants were randomized 2:1:1 to a prebiotic fibre‐enriched nutritional formula (Active), a placebo fibre‐absent nutritional formula (Placebo), or non‐blinded dietary advice alone (Diet). Primary endpoint was change in core Type 2 Diabetes Distress Assessment System (cT2‐DDAS) at week 12. Glycated haemoglobin (HbA1c) change was a key secondary endpoint. Results In total, 192 participants were randomized. Mean age was 54.3 years, HbA1c 7.8%, and body mass index 35.9 kg/m 2 . At week 12, cT2‐DDAS reduced significantly in Active versus Placebo (−0.4, p = .03), and HbA1c was reduced significantly in Active vs Placebo (−0.64%, p = .01). Gut microbiome sequencing revealed that the relative abundance of two species of butyrate‐producing bacteria ( Roseburia faecis and Anaerostipes hadrus ) increased significantly in Active vs. Placebo. Conclusions A microbiome‐targeting nutritional formula significantly improved cT2‐DDAS and HbA1c, suggesting the potential for prebiotic fibre as a complement to lifestyle and/or pharmaceutical interventions for managing type 2 diabetes.