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- Title
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.
- Authors
Frias, Juan P.; Lee, Martin L.; Carter, Matthew M.; Ebel, Emily R.; Lai, Ren‐Hau; Rikse, Lars; Washington, Marc E.; Sonnenburg, Justin L.; Damman, Christopher J.
- 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/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. 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.
- Subjects
GUT microbiome; GLYCEMIC control; TYPE 2 diabetes; HEMOGLOBINS; PSYCHOLOGICAL distress; QUALITY of life
- Publication
Diabetes, Obesity & Metabolism, 2023, Vol 25, Issue 5, p1203
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.14967