10.14.21
Kaneka Probiotics has completed the self-affirmation process to qualify its newest cognitive health-positioned probiotic strain, Floradapt Brain (Lactobacillus plantarum DR7) as GRAS (generally recognized as safe), in accordance with FDA guidance for independent GRAS conclusions.
The GRAS panel concluded that DR7 is not harmful under the conditions of its intended use after reviewing clinical trials, phenotypic data, and genotypic analysis. The published clinical trials for the strain and species were evaluated for evidence of safety and the absence of adverse effects.
According to research on the strain, Lactobacillus plantarum DR7 may promote healthy brain metabolism by upregulating the tryptophan-serotonin pathway by driving the tryptophan metabolic pathway toward serotonin, instead of the kynurenine degradation pathway, which is associated with immunosuppression.
This modulation may be one of several mechanisms involved in a double-blind, placebo-controlled human clinical trial, appearing in the journal Beneficial Microbes, which concluded that in a population of 111 participants, those who supplemented daily with the probiotic resulted in reduced blood concentrations of cortisol, a host of pro-inflammatory cytokines, and improvements in global cognitive function assessments compared to placebo. Furthermore, supplementation also achieved reductions in self-reported symptoms of stress and anxiety in the participants.
“The neurochemistry of the brain is one of the most exciting new playgrounds for probiotics,” Mike Kolifrath, vice president, Sales and Marketing of the Probiotics Division at Kaneka, said. “We have the most competent strain in the gut-brain axis field with L. plantarum DR7, based on its unique ability to impact the biosynthesis of serotonin. The conclusion o the GRAS panel that Lactobacillus plantarum DR7 is GRAS under the conditions of its intended use is confirmation of the quality, safety, and scientific rigor behind our proprietary DR7 strain.”
In addition to its clinical foundation, the strain is not genetically-engineered, is gluten-free, and is approved by the European Food Safety Authority by means of Qualified Presumption of Safety (QPS).
The GRAS panel concluded that DR7 is not harmful under the conditions of its intended use after reviewing clinical trials, phenotypic data, and genotypic analysis. The published clinical trials for the strain and species were evaluated for evidence of safety and the absence of adverse effects.
According to research on the strain, Lactobacillus plantarum DR7 may promote healthy brain metabolism by upregulating the tryptophan-serotonin pathway by driving the tryptophan metabolic pathway toward serotonin, instead of the kynurenine degradation pathway, which is associated with immunosuppression.
This modulation may be one of several mechanisms involved in a double-blind, placebo-controlled human clinical trial, appearing in the journal Beneficial Microbes, which concluded that in a population of 111 participants, those who supplemented daily with the probiotic resulted in reduced blood concentrations of cortisol, a host of pro-inflammatory cytokines, and improvements in global cognitive function assessments compared to placebo. Furthermore, supplementation also achieved reductions in self-reported symptoms of stress and anxiety in the participants.
“The neurochemistry of the brain is one of the most exciting new playgrounds for probiotics,” Mike Kolifrath, vice president, Sales and Marketing of the Probiotics Division at Kaneka, said. “We have the most competent strain in the gut-brain axis field with L. plantarum DR7, based on its unique ability to impact the biosynthesis of serotonin. The conclusion o the GRAS panel that Lactobacillus plantarum DR7 is GRAS under the conditions of its intended use is confirmation of the quality, safety, and scientific rigor behind our proprietary DR7 strain.”
In addition to its clinical foundation, the strain is not genetically-engineered, is gluten-free, and is approved by the European Food Safety Authority by means of Qualified Presumption of Safety (QPS).
