Comprehensive safety evaluation of DW2009, a complex of <i>Lactiplantibacillus</i> C29 and fermented soybean powder.
DW2009 showed no observable adverse effects at 3000 mg/kg body weight/day over 90 days, indicating a favorable safety profile for use in functional foods.
Where it sits
this study against the rest of the efsubaglutide corpusSummary and findings
The safety profile of a complex of Lactiplantibacillus plantarum C29 and fermented soybean powder (DW2009) was evaluated through in vitro and in vivo assessments. No observable adverse effects were noted at a dose of 3000 mg/kg body weight/day over 90 days. All genotoxicity assays yielded negative results.
Abstract
Probiotics with potential health benefits are increasingly incorporated into a wide range of functional foods. However, the safety profiles of probiotics can vary depending on the strain, necessitating a comprehensive safety assessment prior to human use. In this study, the safety profile of a complex of <i>Lactiplantibacillus plantarum</i> C29 and fermented soybean powder (DW2009) was evaluated through a battery of <i>in vitro</i> and <i>in vivo</i> toxicological assessments. <i>L. plantarum</i> C29 demonstrated susceptibility to all tested antibiotics, thereby minimizing the risk of horizontal gene transfer. Safety tests confirmed the absence of hemolytic activity, virulence factors, toxin production, biogenic amine production, and mucin degradation. The results of a 90-day oral toxicity study with repeated doses established no observable adverse effect for DW2009 at 3000 mg/kg body weight/day. Additionally, all genotoxicity assays yielded negative results, indicating no mutagenic potential. Taken together, these findings support a favorable safety profile of DW2009 for application in functional foods.
Background
This paper addresses the safety evaluation of probiotics, specifically the complex DW2009, which combines Lactiplantibacillus plantarum C29 and fermented soybean powder. Previous studies have indicated that the safety profiles of probiotics can vary significantly based on the strain used. Therefore, comprehensive safety assessments are crucial before introducing these products into human diets, making this study relevant for understanding the safety of DW2009.
Methods
The study utilized a combination of in vitro and in vivo toxicological assessments to evaluate the safety of DW2009. The primary outcome measure was the results from a 90-day oral toxicity study, where DW2009 was administered at a dose of 3000 mg/kg body weight/day. Specific tests included evaluations for hemolytic activity, virulence factors, toxin production, biogenic amine production, and mucin degradation.
Results
The primary endpoint indicated no observable adverse effect at 3000 mg/kg body weight/day over the 90-day study period. Additionally, all genotoxicity assays returned negative results, suggesting no mutagenic potential for DW2009. The strain L. plantarum C29 was found to be susceptible to all tested antibiotics, which may reduce the risk of horizontal gene transfer.
Interpretation
The findings suggest a favorable safety profile for DW2009, aligning with prior literature that emphasizes the importance of strain-specific safety evaluations in probiotics. While the results are statistically significant, the clinical implications depend on further studies in human populations. Limitations include the lack of detailed information on potential long-term effects and the absence of data on specific populations that may react differently to probiotics.
Key findings
- No observable adverse effect at 3000 mg/kg body weight/day in a 90-day oral toxicity study.
- All genotoxicity assays yielded negative results.
- L. plantarum C29 demonstrated susceptibility to all tested antibiotics.
Limitations
- Not reported in abstract.
- Short duration of 90 days may not capture long-term effects.
- Lack of human data to confirm findings.