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

Martha Villar-López, Percy Soto-Becerra, Ruth Curse Choque, Ali Al-kassab-Córdova, Félix Bernuy-Barrera, Henry Palomino, Percy A. Rojas, Carmela Vera, Gabriela Lugo-Martínez, Edward Mezones-Holguín

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)906-913
Number of pages8
JournalGynecological Endocrinology
Volume37
Issue number10
DOIs
StatePublished - 2021

Keywords

  • Herbal supplement
  • adult women
  • citrus flavonoids
  • glucosinolates
  • phytosterols
  • safety
  • tolerability

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