08.07.20
Pendulum recently announced the publication of a clinical trial on its novel probiotic product, Pendulum Glucose Control, the first probiotic to receive a medical food designation for the management of type 2 diabetes. As such, it is defined as a food formulated to be consumed under the supervision of a physician for the specific dietary management of a disease. The formulation is branded as a "medical probiotic" as opposed to a dietary supplement on the packaging.
The clinical trial showed the unique blend of novel probiotic strains and a proprietary prebiotic fiber that the company said cannot be found anywhere else on the market has the ability to reduce A1C and blood glucose concentrations in people with type 2 diabetes.
The multi-site, double-blind, placebo-controlled, and randomized clinical study was published in the British Medical Journal. Participants in the study had type 2 diabetes, and were either managing it through exercise and diet alone or in combination with metformin, a drug that lowers blood glucose levels.
Following 12 weeks of daily supplementation with the probiotic formula, it was found that the participants who received Pendulum’s formulation experienced a 33% decrease in post-meal blood glucose spikes, and a 0.6% decrease in hemoglobin A1C, compared to the placebo group. The authors reported that the product was well-tolerated, and no safety issues were observed in the study.
“The research demonstrates that the administration of microbial species, selected for their known beneficial functions in the microbiome, is a promising new tool that augments the traditional dietary measures for improving glucose control in type 2 diabetes, and it is well-established that improved glucose control reduces the risk for devastating long-term complications of diabetes,” Orville Kolterman, MD, chief medical officer of Pendulum Therapeutics and senior author of the study, said.
The product contains fully DNA-sequenced, novel strains of probiotics, and Pendulum was able to characterize their microbial mechanisms during the use of its proprietary technology to discover the new strains.
The targeted strains are designed to replenish lost functions within the gut microbiome that have been observed in people with type 2 diabetes. The product claims to work by restoring a lost fiber metabolism function that is often disrupted by the disease, and is proven to maximize the benefits of dietary fiber despite this complication.
The strains’ mechanism of action involves metabolizing fiber to 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, two symptoms of type 2 diabetes which are key targets for pharmaceutical manufacturers attempting to mitigate diabetes-related complications.
“The link between health, metabolism, and the gut microbiome is generating a high level of interest and scientific research,” Carol Wysham, MD, clinical professor of medicine, clinical endocrinologist, and president elect of the Endocrine Society, said. “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 are 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.”
Each of the probiotic strains within Pendulum Glucose Control have GRAS (Generally Recognized As Safe) status. The five strains are Clostridium beijerinckii WB-STR-0005, Clostridium butyricum WB-STR-0006, Akkermansia muciniphila WB-STR-0001, Eubacterium hallii WB-STR-0008, and Bifidobacterium infantis 100. The prebiotic fiber used in the product is chicory inulin. The capsules are vegan, dairy-free, Non-GMO Project Verified, and gluten-free, and are meant to be taken with food twice daily.
The clinical trial showed the unique blend of novel probiotic strains and a proprietary prebiotic fiber that the company said cannot be found anywhere else on the market has the ability to reduce A1C and blood glucose concentrations in people with type 2 diabetes.
The multi-site, double-blind, placebo-controlled, and randomized clinical study was published in the British Medical Journal. Participants in the study had type 2 diabetes, and were either managing it through exercise and diet alone or in combination with metformin, a drug that lowers blood glucose levels.
Following 12 weeks of daily supplementation with the probiotic formula, it was found that the participants who received Pendulum’s formulation experienced a 33% decrease in post-meal blood glucose spikes, and a 0.6% decrease in hemoglobin A1C, compared to the placebo group. The authors reported that the product was well-tolerated, and no safety issues were observed in the study.
“The research demonstrates that the administration of microbial species, selected for their known beneficial functions in the microbiome, is a promising new tool that augments the traditional dietary measures for improving glucose control in type 2 diabetes, and it is well-established that improved glucose control reduces the risk for devastating long-term complications of diabetes,” Orville Kolterman, MD, chief medical officer of Pendulum Therapeutics and senior author of the study, said.
The product contains fully DNA-sequenced, novel strains of probiotics, and Pendulum was able to characterize their microbial mechanisms during the use of its proprietary technology to discover the new strains.
The targeted strains are designed to replenish lost functions within the gut microbiome that have been observed in people with type 2 diabetes. The product claims to work by restoring a lost fiber metabolism function that is often disrupted by the disease, and is proven to maximize the benefits of dietary fiber despite this complication.
The strains’ mechanism of action involves metabolizing fiber to 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, two symptoms of type 2 diabetes which are key targets for pharmaceutical manufacturers attempting to mitigate diabetes-related complications.
“The link between health, metabolism, and the gut microbiome is generating a high level of interest and scientific research,” Carol Wysham, MD, clinical professor of medicine, clinical endocrinologist, and president elect of the Endocrine Society, said. “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 are 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.”
Each of the probiotic strains within Pendulum Glucose Control have GRAS (Generally Recognized As Safe) status. The five strains are Clostridium beijerinckii WB-STR-0005, Clostridium butyricum WB-STR-0006, Akkermansia muciniphila WB-STR-0001, Eubacterium hallii WB-STR-0008, and Bifidobacterium infantis 100. The prebiotic fiber used in the product is chicory inulin. The capsules are vegan, dairy-free, Non-GMO Project Verified, and gluten-free, and are meant to be taken with food twice daily.
