Universidad Peruana Cayetano Heredia

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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dc.contributor.author Villar-López, Martha
dc.contributor.author Soto Becerra, Percy
dc.contributor.author Curse Choque, Ruth
dc.contributor.author Al-Kassab-Córdova, Ali
dc.contributor.author Bernuy-Barrera, Félix
dc.contributor.author Palomino, Henry
dc.contributor.author Rojas, Percy A.
dc.contributor.author Vera, Carmela
dc.contributor.author Lugo-Martínez, Gabriela
dc.contributor.author Mezones-Holguín, Edward
dc.date.accessioned 2021-10-04T23:01:00Z
dc.date.available 2021-10-04T23:01:00Z
dc.date.issued 2021
dc.identifier.uri https://hdl.handle.net/20.500.12866/9885
dc.description.abstract 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 en_US
dc.language.iso eng
dc.publisher Taylor and Francis
dc.relation.ispartofseries Gynecological Endocrinology
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject adult women en_US
dc.subject citrus flavonoids en_US
dc.subject glucosinolates en_US
dc.subject Herbal supplement en_US
dc.subject phytosterols en_US
dc.subject safety en_US
dc.subject tolerability en_US
dc.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 en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1080/09513590.2021.1960965
dc.relation.issn 1473-0766


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