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To investigate a prebiotic fibre‐enriched nutritional formula on health‐related quality of life and metabolic control in type 2 diabetes.

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.

In 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 …