Probiotic for blood glucose levels receives clinical backing

21 Jul 2020 --- Medical probiotic Pendulum Glucose Control has demonstrated both clinically and statistically significant improvements to A1C (a form of hemoglobin often indicative of diabetes) and blood glucose spikes in people with Type 2 diabetes, according to a new clinical study published in BMJ Open Diabetes Research & Care. These findings, according to the company, display the ability of the novel probiotic strains to provide dietary management of blood glucose control through the gut microbiome.

“The research demonstrates that the administration of microbial species, selected for their known beneficial functions in the microbiome, is a promising tool that augments the traditional dietary measures for improving glucose control in Type 2 diabetes,” says Orville Kolterman, Chief Medical Officer of Pendulum Therapeutics, and senior author of the study.

The multi-site, double-blinded, placebo-controlled, randomized, nutrition study was performed in people with Type 2 diabetes on a background of diet and exercise alone or in combination with metformin, a heterogeneity that is a potential confounder in the study. Results demonstrated a statistically significant improvement in A1C and blood glucose control after 12-week administration of Pendulum’s novel synbiotic formulation, Pendulum Glucose Control. 

Researchers assessed the metabolic effect by measuring changes in blood glucose spikes after a meal in subjects receiving the medical probiotic formulation compared to those receiving placebo. 

“It is well established that improved glucose control reduces the risk for the devastating long-term complications of diabetes,” says Kolterman.

Pendulum was able to identify fully DNA-sequenced, novel strains of probiotics and characterize their microbial mechanisms of action.At 12 weeks, the data showed that those who received Pendulum’s formulation experienced a 33 percent decrease in post-meal blood glucose spikes and a 0.6 percent decrease in hemoglobin A1C relative to the placebo. The product was well-tolerated and no safety issues were observed in the study.

“The link between health, metabolism and the gut microbiome is generating a high level of interest and scientific research,” says Carol Wysham, Clinical Professor of Medicine, Clinical Endocrinologist and President-Elect of the Endocrine Society. 

Pendulum Glucose Control was launched at the start of June. “We are taking a new approach to managing Type 2 diabetes through the gut microbiome with the launch of Pendulum Glucose Control. It’s the first and only medical probiotic clinically shown to lower A1C and blood sugar spikes,” Dr. Colleen Cutcliffe, Pendulum Co-Founder and CEO, told NutritionInsight at the time.

Discovering probiotics
Through its proprietary discovery platform, Pendulum was able to identify fully DNA-sequenced, novel strains of probiotics and characterize their microbial mechanisms of action. The specific strains in Pendulum Glucose Control are designed to replenish lost functions within the gut microbiome observed in people with Type 2 diabetes by helping to metabolize fiber and produce butyrate – a short-chain fatty acid that binds to G-protein coupled receptors to stimulate GLP-1 release. GLP-1 is a hormone known to decrease post-meal glucose spikes and A1C.

“We are only just scratching the surface regarding microbiome-based interventions that have the ability to improve health. These interventions must pose no safety risks and be backed by solid scientific research. Pendulum is a pioneer in using DNA sequencing technology to develop novel formulations of bacterial strains that target specific deficits in the microbiome associated with metabolic dysfunction,” adds Wysham. 

Pendulum Glucose Control contains five strains of anaerobic bacteria, including Clostridium beijerinckii WB-STR-0005, Clostridium butyricum WB-STR-0006, Akkermansia muciniphila WB-STR-0001, Eubacterium hallii WB-STR-0008, Bifidobacterium infantis 100 as well as a prebiotic. 

Each of the microbes in Pendulum Glucose Control have been fully characterized and have been reviewed and affirmed as GRAS (Generally Recognized as Safe) by an independent third-party organization. However, this formulation of beneficial bacteria and prebiotic is not currently available in any probiotic marketed today. 

It is a medical food intended for use only under physician supervision for dietary management of Type 2 diabetes and as part of a total diabetes management plan. Whether this will pave the way for other types of probiotics to manage glucose levels remains to be seen. 

Meanwhile, bioactive peptides have also been highlighted for their potential to tackle Type 2 diabetes. Last year, Ingredia released Pep2Dia, which is touted for reducing the likelihood of Type 2 diabetes to develop in those who are pre-diabetic. 

By Missy Green