Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel.
Toxicol Rep
; 8: 1229-1239, 2021.
Article
em En
| MEDLINE
| ID: mdl-34195014
ABSTRACT
Coenzyme Q10 (CoQ10) supplementation has demonstrated to be safe and effective in primary and secondary CoQ10 deficiencies. Previously, we have designed a high-dose CoQ10 oleogel (1â¯g/disk) with excipients used in quantities that do not represent any toxic risk. However, it was necessary to demonstrate their safety in the final formulation. Following this purpose, an acute toxicity study of the oleogel in rats was performed. Furthermore, the genotoxic risk was evaluated in human volunteers after CoQ10 supplementation with oleogel and compared to the solid form (1â¯g/three 00-size-capsules). In addition, the general health status and possible biochemical changes of the participants were determined using serum parameters. Results suggested the absence of adverse effects caused by the interaction of the components in the oleogel formulation. Therefore, we conclude that the designed novel high-dose CoQ10 oleogel was safe for oral consumption.
ALKP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CBMNcyt, cytokinesis-block micronucleus cytome; CoQ10, coenzyme Q10; EC, ethylcellulose; GGT, gamma-glutamyl transferase; Genotoxicity; High-dose coenzyme Q10 oleogel; LDH, lactate dehydrogenase; MCT, Medium-chain Triglycerides; MNi, micronuclei; Micronucleus cytome assay; NBUDs, nuclear buds; NPBs, nucleoplasmic bridges; Rat acute toxicity; Serum biochemical parameters
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Etiology_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Toxicol Rep
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Argentina