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

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.

Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

“…We found that direct‐to‐patient shipping procedures are suitable to DCT designs, but detailed management also needs to be warranted as guided in Good Clinical Practice (e.g., identification of the recipients, and storage and disposal of the products). We also demonstrated that self‐stool collection procedures could yield analyzable microbiome data and could be utilized in further trials 34 …”

“…We also demonstrated that self-stool collection procedures could yield analyzable microbiome data and could be utilized in further trials. 34 Of note, regulatory guidance for DCTs has recently been published. The guidance from the FDA provides a detailed description of the oversight of study personnel outside of trial sites.…”

Effects of a diverse prebiotic fibre supplement on HbA1c, insulin sensitivity, and inflammatory biomarkers in pre-diabetes: a randomised placebo-controlled clinical trial

“…In this study, authors propose that in the absence of a T2DM diagnosis, this population is less likely to receive timely medical intervention, despite their HbA1c status being only marginally better than that of individuals with T2DM (29). While there are fewer studies in pre-diabetes, there are a number of studies in T2DM that show significant improvements in HbA1c following prebiotic interventions (9, 21, 30, 31). However, the majority of patients in these studies were on stable anti-diabetic medication.…”

Perspective: Nutrition’s Next Chapter – Bioactive Gaps and the Microbiome–Mitochondria Axis

“…Food quality scoring systems that aim to capture elements of the food matrix, including degree of processing, relative ratios of nutrients, and missing bioactives, are being developed [ [29] , [30] , [31] ]. Commercial efforts are starting to provide complementary solutions to nutritional guidance such as smart phone applications to personalize and prioritize the whole food selection as well as next-generation products that reincorporate bioactive ingredients into functional foods [ [32] , [33] , [34] , [35] , [36] , [37] ].…”

“…Bioactives are not essential in the strict nutritional definition of the word, but they play a fundamental role in regulating healthy growth [ 38 ], metabolism [ 35 ], appetite [ 39 ], immunity [ 40 , 41 ], mood [ 42 ], cognition [ 43 ], and longevity [ 44 ]. They may perform this by directly interfacing with energy processing in our cells [ 45 ].…”