A Microbiome-targeting Fiber-enriched Nutritional Formula is Well Tolerated and Improves Quality of Life and Hemoglobin A1c in Type 2 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Trial

ABSTRACT OBJECTIVE To investigate a prebiotic fiber-enriched nutritional formula on health-related quality of life and metabolic control in type 2 diabetes. RESEARCH DESIGN AND METHODS 12-week, double-blind, placebo-controlled trial. Participants were randomized 2:1:1 to a prebiotic fiber-enriched nutritional formula (Active), a placebo fiber-absent nutritional formula (Placebo), or dietary advice alone (Diet). Primary endpoint was change in core Type 2 Diabetes Distress Assessment System (cT2-DDAS) at week 12. HbA1c change was a key secondary endpoint. RESULTS 192 participants were randomized. Mean age was 54.3 years, HbA1c 7.8%, and BMI 35.9 kg/m 2 . At week 12, cT2-DDAS (p=0.03) was reduced significantly in Active versus control arms, and HbA1c (p=0.009) was reduced significantly in Active vs Placebo arm. CONCLUSIONS A microbiome-targeting nutritional formula significantly improved cT2-DDAS and HbA1c suggesting the potential for prebiotic fiber as a complement to lifestyle and/or pharmaceutical interventions for managing type 2 diabetes.