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Kaneka self-affirms GRAS status for gut-brain axis DR7 probiotic

© ChrisChrisW / Getty Images
© ChrisChrisW / Getty Images

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Texas-based Kaneka has announced that it has completed the self-affirmation Generally Recognized as Safe (GRAS) process for its Floradapt Brain (Lactobacillus plantarum DR7) probiotic.

In accordance with FDA guidance regarding independent GRAS conclusions, data from published clinical trials, phenotypic data, and genotypic analysis supported the safety of the strain under the conditions of its intended use.

“The conclusion of 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,”​ said Mike Kolifrath, Vice President, Sales and Marketing of the Probiotics Division at Kaneka.

Gut-Brain Axis

The DR7 strain was isolated originally from fresh bovine milk and is supported by published clinical trials, including a paper in the journal Beneficial Microbes*​ that reported that one billion CFUs of DR7 per day was associated with improved cognitive and memory functions in normal adults compared to placebo, and these improvements were noted for basic attention, emotional cognition, and associate learning.

The strain is reported to support healthy brain metabolism by upregulating the Tryptophan-Serotonin pathway by driving the tryptophan metabolic pathway towards Serotonin, instead of the kyneurine degradation pathway. By upregulating the tryptophan-serotonin pathway, there is a de-emphasis of the tryptophan-kyneurine pathway, which is associated with a weaker immunity. 

“The neurochemistry of the brain is one of the most exciting new playgrounds of probiotics,” ​added Kolifrath. “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 strain’s potential benefits for respiratory health were reported in a randomized-controlled clinical trial published in the Journal of Dairy Science​**. The study included 109 adults randomly assigned to receive either one billion CFUs of DR7 per day or placebo for 12 weeks. The data indicated that the probiotic was associated with decreased levels of pro-inflammatory cytokines such as TNF-alpha and IFN-gamma in the subjects, as well as reduced the duration of nasal symptoms.

* Beneficial Microbes
2019, Volume 10, Issue 4, Pages 355-373, doi: 10.3920/BM2018.0135
Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study”
Authors: H-X Chong, et al.

** Journal of Dairy Science
2019, Volume 102, Issue 6, Pages 4783-4797, doi: 10.3168/jds.2018-16103
Lactobacillus plantarum DR7 improved upper respiratory tract infections via enhancing immune and inflammatory parameters: A randomized, double-blind, placebo-controlled study
Authors: H-X Chong, et al.



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