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

AbstractAimsTo investigate a prebiotic fibre‐enriched nutritional formula on health‐related quality of life and metabolic control in type 2 diabetes.Materials and MethodsThis 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.ResultsIn total, 192 participants were randomized. Mean age was 54.3 years, HbA1c 7.8%, and body mass index 35.9 kg/m2. 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.ConclusionsA 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.