Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial

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El texto completo de este trabajo no está disponible en el Repositorio Académico UPC por restricciones de la casa editorial donde ha sido publicado.
Detalles Bibliográficos
Autores: Villar-López, Martha, Soto-Becerra, Percy, Curse Choque, Ruth, Al-kassab-Córdova, Ali, Bernuy-Barrera, Félix, Palomino, Henry, Rojas, Percy A., Vera, Carmela, Lugo-Martínez, Gabriela, Mezones-Holguín, Edward
Formato: artículo
Fecha de Publicación:2021
Institución:Universidad Peruana de Ciencias Aplicadas
Repositorio:UPC-Institucional
Lenguaje:inglés
OAI Identifier:oai:repositorioacademico.upc.edu.pe:10757/658457
Enlace del recurso:http://hdl.handle.net/10757/658457
Nivel de acceso:acceso embargado
Materia:adult women
citrus flavonoids
glucosinolates
Herbal supplement
phytosterols
safety
tolerability
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network_acronym_str UUPC
network_name_str UPC-Institucional
repository_id_str 2670
dc.title.es_PE.fl_str_mv Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
title Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
spellingShingle Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
Villar-López, Martha
adult women
citrus flavonoids
glucosinolates
Herbal supplement
phytosterols
safety
tolerability
title_short Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
title_full Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
title_fullStr Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
title_full_unstemmed Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
title_sort Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
author Villar-López, Martha
author_facet Villar-López, Martha
Soto-Becerra, Percy
Curse Choque, Ruth
Al-kassab-Córdova, Ali
Bernuy-Barrera, Félix
Palomino, Henry
Rojas, Percy A.
Vera, Carmela
Lugo-Martínez, Gabriela
Mezones-Holguín, Edward
author_role author
author2 Soto-Becerra, Percy
Curse Choque, Ruth
Al-kassab-Córdova, Ali
Bernuy-Barrera, Félix
Palomino, Henry
Rojas, Percy A.
Vera, Carmela
Lugo-Martínez, Gabriela
Mezones-Holguín, Edward
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Villar-López, Martha
Soto-Becerra, Percy
Curse Choque, Ruth
Al-kassab-Córdova, Ali
Bernuy-Barrera, Félix
Palomino, Henry
Rojas, Percy A.
Vera, Carmela
Lugo-Martínez, Gabriela
Mezones-Holguín, Edward
dc.subject.es_PE.fl_str_mv adult women
citrus flavonoids
glucosinolates
Herbal supplement
phytosterols
safety
tolerability
topic adult women
citrus flavonoids
glucosinolates
Herbal supplement
phytosterols
safety
tolerability
description El texto completo de este trabajo no está disponible en el Repositorio Académico UPC por restricciones de la casa editorial donde ha sido publicado.
publishDate 2021
dc.date.accessioned.none.fl_str_mv 2022-01-05T14:16:30Z
dc.date.available.none.fl_str_mv 2022-01-05T14:16:30Z
dc.date.issued.fl_str_mv 2021-01-01
dc.type.es_PE.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.issn.none.fl_str_mv 09513590
dc.identifier.doi.none.fl_str_mv 10.1080/09513590.2021.1960965
dc.identifier.uri.none.fl_str_mv http://hdl.handle.net/10757/658457
dc.identifier.eissn.none.fl_str_mv 14730766
dc.identifier.journal.es_PE.fl_str_mv Gynecological Endocrinology
dc.identifier.eid.none.fl_str_mv 2-s2.0-85112188291
dc.identifier.scopusid.none.fl_str_mv SCOPUS_ID:85112188291
dc.identifier.isni.none.fl_str_mv 0000 0001 2196 144X
identifier_str_mv 09513590
10.1080/09513590.2021.1960965
14730766
Gynecological Endocrinology
2-s2.0-85112188291
SCOPUS_ID:85112188291
0000 0001 2196 144X
url http://hdl.handle.net/10757/658457
dc.language.iso.es_PE.fl_str_mv eng
language eng
dc.relation.url.es_PE.fl_str_mv https://www.tandfonline.com/doi/abs/10.1080/09513590.2021.1960965?journalCode=igye20
dc.rights.es_PE.fl_str_mv info:eu-repo/semantics/embargoedAccess
eu_rights_str_mv embargoedAccess
dc.format.es_PE.fl_str_mv application/html
dc.publisher.es_PE.fl_str_mv Taylor and Francis Ltd.
dc.source.es_PE.fl_str_mv Universidad Peruana de Ciencias Aplicadas (UPC)
Repositorio Academico - UPC
dc.source.none.fl_str_mv reponame:UPC-Institucional
instname:Universidad Peruana de Ciencias Aplicadas
instacron:UPC
instname_str Universidad Peruana de Ciencias Aplicadas
instacron_str UPC
institution UPC
reponame_str UPC-Institucional
collection UPC-Institucional
dc.source.journaltitle.none.fl_str_mv Gynecological Endocrinology
dc.source.volume.none.fl_str_mv 37
dc.source.issue.none.fl_str_mv 10
dc.source.beginpage.none.fl_str_mv 906
dc.source.endpage.none.fl_str_mv 913
bitstream.url.fl_str_mv https://repositorioacademico.upc.edu.pe/bitstream/10757/658457/1/license.txt
bitstream.checksum.fl_str_mv 8a4605be74aa9ea9d79846c1fba20a33
bitstream.checksumAlgorithm.fl_str_mv MD5
repository.name.fl_str_mv Repositorio académico upc
repository.mail.fl_str_mv upc@openrepository.com
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spelling c911cb17a39afba7b4fae2b42aaab9e93005090804266660a87a4b382cef59f697c500713e8c7edfdba31cf3b4ea3e8227c0b3300ac7a965491b9037e4d244ca2ab9ca02965078ff9bf43eb51e38039c2f3b68da93009132a5e33a37766e1c243b2a654c6f7e6184605552af1e29ecdf3ead3e1ca6f5300fbe29f99f76bacaf9fb361fef75196973009a02776ce22faf46280bb095ec2c13a23001f28a07bd389af46a62cfc6f88179f34500Villar-López, MarthaSoto-Becerra, PercyCurse Choque, RuthAl-kassab-Córdova, AliBernuy-Barrera, FélixPalomino, HenryRojas, Percy A.Vera, CarmelaLugo-Martínez, GabrielaMezones-Holguín, Edward2022-01-05T14:16:30Z2022-01-05T14:16:30Z2021-01-010951359010.1080/09513590.2021.1960965http://hdl.handle.net/10757/65845714730766Gynecological Endocrinology2-s2.0-85112188291SCOPUS_ID:851121882910000 0001 2196 144XEl texto completo de este trabajo no está disponible en el Repositorio Académico UPC por restricciones de la casa editorial donde ha sido publicado.Objective: To evaluate the safety and tolerability of an oral herbal supplement containing glucosinolates, phytosterols, and citrus flavonoids (Warmi®, Lima Perú;) in otherwise healthy adult women. Methods: This was a phase-I, randomized parallel three arms, double-blinded, and a placebo-controlled clinical trial. A total of 55 participants aged 18-40 were randomly assigned to one of three groups to receive for three months: (1) an oral herbal supplement of 1650 mg/day; (2) an oral herbal supplement of 3300 mg/day; or (3) an oral placebo 3300 mg/day. The primary endpoints were oral safety and tolerability of the supplement. The secondary endpoint was its effect on vital functions, anthropometrics, and laboratory tests. We used an exploratory approach by covariance analysis (ANCOVA) adjusted for the variables’ baseline value for the secondary outcomes. Results: All women completed three months of follow-up, reporting no side effects. Our exploratory analysis revealed that treatment with the herbal supplement of 1650 mg/day was associated with increased glucose and uric acid levels. In comparison, the herbal supplement 3300 mg/day was associated with reduced breathing rate, increased basal temperature, and systolic blood pressure, both compared to the placebo group. However, despite significant differences, none of these was clinically significant. Conclusion: The oral herbal supplement had a favorable safety and tolerability profile in studied women. There is a need to study its potential as an option to treat menopausal symptoms.Revisión por paresapplication/htmlengTaylor and Francis Ltd.https://www.tandfonline.com/doi/abs/10.1080/09513590.2021.1960965?journalCode=igye20info:eu-repo/semantics/embargoedAccessUniversidad Peruana de Ciencias Aplicadas (UPC)Repositorio Academico - UPCGynecological Endocrinology3710906913reponame:UPC-Institucionalinstname:Universidad Peruana de Ciencias Aplicadasinstacron:UPCadult womencitrus flavonoidsglucosinolatesHerbal supplementphytosterolssafetytolerabilitySafety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trialinfo:eu-repo/semantics/articleLICENSElicense.txtlicense.txttext/plain; charset=utf-81748https://repositorioacademico.upc.edu.pe/bitstream/10757/658457/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51false10757/658457oai:repositorioacademico.upc.edu.pe:10757/6584572022-01-05 14:16:31.421Repositorio académico upcupc@openrepository.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Safety and tolerability of a natural supplement containing glucosinolates, phytosterols and citrus flavonoids in adult women: a randomized phase I, placebo-controlled, multi-arm, double-blinded clinical trial
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