Fibre supplements for pre-diabetes (FLORA)
Research type
Research Study
Full title
Fibre Supplements for pre-diabetes (FLORA)
IRAS ID
318937
Contact name
John Luke Twelves
Contact email
Sponsor organisation
Myota GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 16 days
Research summary
13.6 million people in the UK have pre-diabetes and are at increased risk of developing type 2 diabetes. It is well understood that dietary fibre contributes to a healthy metabolism and maintenance of insulin sensitivity, which may reduce the risk of developing type 2 diabetes. One of the ways that fibre achieve these effects is through fermentation by the gut microbiome to produce Short Chain Fatty Acids (SCFAs). It is SCFAs which help to maintain healthy blood glucose levels.
Due to differences in gut microbiome's, individuals consuming the same dietary fibre often produce different quantities of SCFAs. This means that different individuals would respond better to different individual fibres. Myota has extensively studied the fermentation capabilities across 80 individuals, to enable the calculation of mixtures of fibres that result in the most SCFA production on average across individuals.
The aim of the trial is to find out whether the Myota Metabolic Regulator (fibre mix) improves clinical biomarkers for people identified as having pre-diabetes, i.e. glycaemic responses (HbA1c, oral glucose tolerance, and fasting blood glucose). Patients will be randomised to either intervention (fibre mix daily alongside usual diet) or control (placebo alongside usual diet) and blood tests for clinical biomarkers will be completed at baseline, 16 and 24 weeks.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0363
Date of REC Opinion
1 Nov 2022
REC opinion
Further Information Favourable Opinion