Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel

Autores
Ehrenhaus Masotta, Natalia; Martínez Perafán, Fabián Humberto; Carballo, Marta Ana; Gorzalczany, Susana Beatriz; Rojas, Ana Maria Luisa; Tripodi, Valeria Paula
Año de publicación
2021
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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 (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 CoQ10 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 CoQ10 oleogel was safe for oral consumption.
Fil: Ehrenhaus Masotta, Natalia. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Departamento de Industrias. Instituto de Tecnología de Alimentos y Procesos Químicos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Tecnología de Alimentos y Procesos Químicos; Argentina
Fil: Martínez Perafán, Fabián Humberto. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Carballo, Marta Ana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Gorzalczany, Susana Beatriz. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Rojas, Ana Maria Luisa. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Departamento de Industrias. Instituto de Tecnología de Alimentos y Procesos Químicos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Tecnología de Alimentos y Procesos Químicos; Argentina
Fil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
Materia
HIGH-DOSE COENZYME Q10 OLEOGEL
RAT ACUTE TOXICITY
GENOTOXOCITY
MICRONUCLEOUS CYTOME ASSAY
SERUM BIOCHEMICAL PARAMETERS
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/155546
Acceder
id CONICETDig_22a4739327b724b12d3373e187567687
oai_identifier_str oai:ri.conicet.gov.ar:11336/155546
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogelEhrenhaus Masotta, NataliaMartínez Perafán, Fabián HumbertoCarballo, Marta AnaGorzalczany, Susana BeatrizRojas, Ana Maria LuisaTripodi, Valeria PaulaHIGH-DOSE COENZYME Q10 OLEOGELRAT ACUTE TOXICITYGENOTOXOCITYMICRONUCLEOUS CYTOME ASSAYSERUM BIOCHEMICAL PARAMETERShttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Coenzyme 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 (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 CoQ10 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 CoQ10 oleogel was safe for oral consumption.Fil: Ehrenhaus Masotta, Natalia. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Departamento de Industrias. Instituto de Tecnología de Alimentos y Procesos Químicos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Tecnología de Alimentos y Procesos Químicos; ArgentinaFil: Martínez Perafán, Fabián Humberto. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; ArgentinaFil: Carballo, Marta Ana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; ArgentinaFil: Gorzalczany, Susana Beatriz. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Rojas, Ana Maria Luisa. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Departamento de Industrias. Instituto de Tecnología de Alimentos y Procesos Químicos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Tecnología de Alimentos y Procesos Químicos; ArgentinaFil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaElsevier2021-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/155546Ehrenhaus Masotta, Natalia; Martínez Perafán, Fabián Humberto; Carballo, Marta Ana; Gorzalczany, Susana Beatriz; Rojas, Ana Maria Luisa; et al.; Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel; Elsevier; Toxicology Reports; 8; 6-2021; 1229-12392214-7500CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2214750021001165info:eu-repo/semantics/altIdentifier/doi/10.1016/j.toxrep.2021.06.012info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:34:01Zoai:ri.conicet.gov.ar:11336/155546instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 09:34:01.611CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
title Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
spellingShingle Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
Ehrenhaus Masotta, Natalia
HIGH-DOSE COENZYME Q10 OLEOGEL
RAT ACUTE TOXICITY
GENOTOXOCITY
MICRONUCLEOUS CYTOME ASSAY
SERUM BIOCHEMICAL PARAMETERS
title_short Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
title_full Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
title_fullStr Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
title_full_unstemmed Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
title_sort Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel
dc.creator.none.fl_str_mv Ehrenhaus Masotta, Natalia
Martínez Perafán, Fabián Humberto
Carballo, Marta Ana
Gorzalczany, Susana Beatriz
Rojas, Ana Maria Luisa
Tripodi, Valeria Paula
author Ehrenhaus Masotta, Natalia
author_facet Ehrenhaus Masotta, Natalia
Martínez Perafán, Fabián Humberto
Carballo, Marta Ana
Gorzalczany, Susana Beatriz
Rojas, Ana Maria Luisa
Tripodi, Valeria Paula
author_role author
author2 Martínez Perafán, Fabián Humberto
Carballo, Marta Ana
Gorzalczany, Susana Beatriz
Rojas, Ana Maria Luisa
Tripodi, Valeria Paula
author2_role author
author
author
author
author
dc.subject.none.fl_str_mv HIGH-DOSE COENZYME Q10 OLEOGEL
RAT ACUTE TOXICITY
GENOTOXOCITY
MICRONUCLEOUS CYTOME ASSAY
SERUM BIOCHEMICAL PARAMETERS
topic HIGH-DOSE COENZYME Q10 OLEOGEL
RAT ACUTE TOXICITY
GENOTOXOCITY
MICRONUCLEOUS CYTOME ASSAY
SERUM BIOCHEMICAL PARAMETERS
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv 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 (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 CoQ10 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 CoQ10 oleogel was safe for oral consumption.
Fil: Ehrenhaus Masotta, Natalia. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Departamento de Industrias. Instituto de Tecnología de Alimentos y Procesos Químicos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Tecnología de Alimentos y Procesos Químicos; Argentina
Fil: Martínez Perafán, Fabián Humberto. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Carballo, Marta Ana. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Instituto de Fisiopatología y Bioquímica Clínica; Argentina
Fil: Gorzalczany, Susana Beatriz. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina
Fil: Rojas, Ana Maria Luisa. Universidad de Buenos Aires. Facultad de Ciencias Exactas y Naturales. Departamento de Industrias. Instituto de Tecnología de Alimentos y Procesos Químicos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Tecnología de Alimentos y Procesos Químicos; Argentina
Fil: Tripodi, Valeria Paula. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina
description 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 (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 CoQ10 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 CoQ10 oleogel was safe for oral consumption.
publishDate 2021
dc.date.none.fl_str_mv 2021-06
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/155546
Ehrenhaus Masotta, Natalia; Martínez Perafán, Fabián Humberto; Carballo, Marta Ana; Gorzalczany, Susana Beatriz; Rojas, Ana Maria Luisa; et al.; Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel; Elsevier; Toxicology Reports; 8; 6-2021; 1229-1239
2214-7500
CONICET Digital
CONICET
url http://hdl.handle.net/11336/155546
identifier_str_mv Ehrenhaus Masotta, Natalia; Martínez Perafán, Fabián Humberto; Carballo, Marta Ana; Gorzalczany, Susana Beatriz; Rojas, Ana Maria Luisa; et al.; Genotoxic risk in humans and acute toxicity in rats of a novel oral high-dose coenzyme Q10 oleogel; Elsevier; Toxicology Reports; 8; 6-2021; 1229-1239
2214-7500
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S2214750021001165
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.toxrep.2021.06.012
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.070432

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