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
Date Issued
01 January 2021
Access level
metadata only access
Resource Type
journal article
Author(s)
Villar-López M.
Curse Choque R.
Al-kassab-Córdova A.
Bernuy-Barrera F.
Palomino H.
Rojas P.A.
Vera C.
Lugo-Martínez G.
Publisher(s)
Taylor and Francis Ltd.
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.
Start page
906
End page
913
Volume
37
Issue
10
Language
English
OCDE Knowledge area
Anatomía, Morfología Química medicinal Endocrinología, Metabolismo (incluyendo diabetes, hormonas)
Scopus EID
2-s2.0-85112188291
PubMed ID
Source
Gynecological Endocrinology
ISSN of the container
09513590
Sources of information: Directorio de Producción Científica Scopus