Toxicological safety evaluation of pasteurized Akkermansia muciniphila.
J Appl Toxicol
; 41(2): 276-290, 2021 02.
Article
in En
| MEDLINE
| ID: mdl-32725676
ABSTRACT
Gut microorganisms are vital for many aspects of human health, and the commensal bacterium Akkermansia muciniphila has repeatedly been identified as a key component of intestinal microbiota. Reductions in A. muciniphila abundance are associated with increased prevalence of metabolic disorders such as obesity and type 2 diabetes. It was recently discovered that administration of A. muciniphila has beneficial effects and that these are not diminished, but rather enhanced after pasteurization. Pasteurized A. muciniphila is proposed for use as a food ingredient, and was therefore subjected to a nonclinical safety assessment, comprising genotoxicity assays (bacterial reverse mutation and in vitro mammalian cell micronucleus tests) and a 90-day toxicity study. For the latter, Han Wistar rats were administered with the vehicle or pasteurized A. muciniphila at doses of 75, 375 or 1500 mg/kg body weight/day (equivalent to 4.8 × 109 , 2.4 × 1010 , or 9.6 × 1010 A. muciniphila cells/kg body weight/day) by oral gavage for 90 consecutive days. The study assessed potential effects on clinical observations (including detailed arena observations and a modified Irwin test), body weight, food and water consumption, clinical pathology, organ weights, and macroscopic and microscopic pathology. The results of both in vitro genotoxicity studies were negative. No test item-related adverse effects were observed in the 90-day study; therefore, 1500 mg/kg body weight/day (the highest dose tested, equivalent to 9.6 × 1010 A. muciniphila cells/kg body weight/day) was established as the no-observed-adverse-effect-level. These results support that pasteurized A. muciniphila is safe for use as a food ingredient.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Dietary Supplements
/
Food Safety
/
Pasteurization
/
Gastrointestinal Microbiome
/
Akkermansia
Type of study:
Risk_factors_studies
Limits:
Animals
/
Humans
/
Male
Language:
En
Journal:
J Appl Toxicol
Year:
2021
Document type:
Article
Affiliation country:
Belgium