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Coenzyme Q 10 (CoQ 10 ) supplementation has demonstrated to be safe and effective in primary and secondary CoQ 10 deficiencies. Previously, we have designed a high-dose CoQ 10 oleogel (1 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 CoQ 10 supplementation with oleogel and compared to the solid form (1 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 CoQ 10 oleogel was safe for oral consumption., Competing Interests: The authors declare no conflict of interest., (© 2021 Published by Elsevier B.V.)