The randomized, double-blind, placebo-controlled, parallel-group clinical trial published in the journal Nutrients studied the impact of supplementation with YMETA, a new concept comprising galacto-oligosaccharides (GOSs) produced through the β-galactosidase activity of Bifidobacterium breve, exopolysaccharides (EPSs) from B. breve and konjac glucomannan (KGM).
The researchers found supplementation over 12 weeks led to a significant increase in alpha diversity and butyrate-producing bacteria, with reductions in HbA1c (hemoglobin A1c, a measure of the amount of glucose attached to hemoglobin) and FPG (fasted plasma glucose) levels to below prediabetes thresholds.
Jelena Vulevic, one of the researchers and CEO and co-founder at VeMico Ltd, the firm that created the supplement and funded the study, explained how the team created this formulation.
"With data showing our postbiotic's positive effect on barrier function and systemic inflammation and the established link between chronic inflammation, metabolic dysfunction and type 2 diabetes, we decided to test our compound in a prediabetic population," she said. "To maximize effectiveness, we combined the postbiotic with a second-generation prebiotic to address potential dysbiosis alongside barrier function improvement.
"Leveraging our expertise in developing and working with galacto-oligosaccharides (GOS), we used enzymes from our proprietary strain (Bifidobacterium breve BB091109) to create a GOS with specific chemical structures and polymerization degrees for the desired microbiota effect."
Vulevic said the team anticipated positive results but that the resulting data were particularly impressive.
"We expected a positive effect based on our formulation and hypothesis, but the significant change in HbA1c levels within a population that did not alter their dietary habits during the intervention was beyond our expectations," she explained.
"Our next focus is to better understand the mode of action, as our initial experiments suggest a mechanism similar to GLP-1 antagonists. We aim to explore how delivering metabolites from probiotics (postbiotics) directly interacts with epithelial receptors and affects gene expression."
Prediabetes
Prediabetes affects an estimated 5.8% (298 million) of adults between the ages of 20 and 79 with impaired fasting glucose (IFG) and 9.1% (464 million) with impaired glucose tolerance (IGT) worldwide. This metabolic condition, characterized by elevated blood glucose levels, reflects underlying insulin resistance or inadequate pancreatic insulin secretion.
Prebiotic and soluble fiber supplements offer a non-pharmacological approach to modulate gut microbiota composition and activity and improve metabolic health by promoting the growth of beneficial bacteria, as well as mitigating inflammation, enhancing barrier function and amending glucose intolerance.
Study details
Fifty three participants were randomly assigned to either a daily supplement (YMETA) or a placebo (cellulose microcrystalline) for 12 weeks, followed by a four-week follow-up.
Firstly, the researchers conducted a comprehensive assessment of gut health, including gut microbiota composition and intestinal permeability, as well as metabolic function, specifically glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels. Then, they evaluated alterations in anthropometry, body composition, blood pressure (BP) and plasma lipids—total cholesterol (TC), HDL-C, LDL-C, triacylglycerol (TAG), non-HDL-C, and TC to HDL-C ratio (THR).
The intervention group showed a significant increase in alpha diversity and butyrate-producing bacteria, with reductions in HbA1c and FPG levels below prediabetes thresholds. No significant changes were observed in the placebo group.
Regarding limitations, the authors noted food diaries were not used to monitor potential dietary impacts.
Gut and skin formulations
VeMico’s portfolio includes YSKIN, which addresses the aging process, and YGUT sensitive, which targets digestive discomfort and overall gut health. The team is currently collaborating with a company to develop a formulation targeting the gut-brain axis and exploring potential partnerships in the femtech sector. They are open to further collaborations.
Next, the firm aims to develop YMETA, the product from its latest study, in partnership with a company interested in commercialization.
Source: Nutrients
https://doi.org/10.3390/nu16142205
"Impact of Combined Prebiotic Galacto-Oligosaccharides and Bifidobacterium breve-Derived Postbiotic on Gut Microbiota and HbA1c in Prediabetic Adults: A Double-Blind, Randomized, Placebo-Controlled Study"
Authors: Beteri, B.; Barone, M.; Turroni, S.; Brigidi, P.; Tzortzis, G.; Vulevic, J.; Sekulic, K.; Motei, D.-E.; Costabile, A.