FIBRE V1.0
Research type
Research Study
Full title
FIBRE study: Feasibility of an Intervention using precision fibre Blends as a self-management tool in pRE- and type 2 diabetes
IRAS ID
314709
Contact name
Manish Saxena
Contact email
Sponsor organisation
Myota GmbH
Duration of Study in the UK
0 years, 11 months, 23 days
Research summary
It is well recognised that a diet high in fibre contributes to healthy glucose metabolism (Reynolds, Akerman & Mann, 2020). Alongside its ability to reduce post-prandial (post-meal) glucose responses, fibre is fermented by the gut microbiota to produce by-products called Short Chain Fatty Acids (SCFAs). SCFAs have been shown to improve insulin sensitivity and metabolic health by altering intestinal gluconeogenesis(De Vadder et al., 2014; Zhou et al., 2018).
By studying the human gut microbiome’s fermentation capabilities across individuals, myota has created a data-driven and proprietary mixture of powdered dietary fibres called the Metabolic Regulator, aimed at preventing and improving poor glucose control and insulin resistance. There is also a growing patient-driven preference for alternative or adjuvant therapies to self-manage pre-diabetes and T2D at home (before using medication). A simple and cost-effective fibre-based self-management tool represents a promising therapeutic avenue. In this study, we aim to investigate the feasibility and acceptance of a microbiome-motivated fibre mix as a self-management tool in individuals with pre-diabetes and T2D.
The study population will include adults aged 18-75 years with pre-diabetes or T2D (in this study defined as HbA1C 6-6.4% for pre-diabetes; HbA1C >6.4%<8.5% for T2D). Participants will be randomised to the fibre arm (20g of Metabolic Regulator daily alongside usual diet) or control (standard of care). Primary and secondary end-points will be measured at baseline, 16 weeks, and 24 weeks.
REC name
London - Bromley Research Ethics Committee
REC reference
22/LO/0838
Date of REC Opinion
16 Dec 2022
REC opinion
Further Information Favourable Opinion