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/m2. 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.

C.D., M.W., and R.L. are employees of Supergut. C.D. consults for Evolve Biosystems, BCD Biosciences, and Reference Capital. M.L. consults for Supergut. J.F. receives research support from Akero, AstraZeneca, Boehringer Ingelheim, BMS, 89bio, Eli Lilly, Intercept, IONIS, Janssen, Madrigal, Metacrine, Merck, NorthSea Therapeutics, Novartis, Novo Nordisk, Oramed, Pfizer, Poxel, Sanofi, Supergut; is a consultant for Akero, Altimmune, Axcella Health, Becton Dickenson, Boehringer Ingelheim, Carmot Therapeutics, Echosens, 89bio, Eli Lilly, Gilead, Intercept, LifeScan, Metacrine, Merck, Novo Nordisk, Pfizer, Sanofi, Supergut; is on speakers bureaus for Eli Lilly and Sanofi.

NCT05110703

The project was supported by funds provided by UR Labs/Supergut.

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