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.

What Was Tested

The paper reports a study of Copper (Supplement), published as a randomized controlled trial.

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.

Who Took Part

According to the abstract, 55 participants were involved.

PubMed indexes the participants as adults, women only.

The primary endpoints were oral safety and tolerability of the supplement.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and parallel-group.

The participants were allocated by chance, so the Copper (Supplement) group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Copper (Supplement).

A placebo (an inactive look-alike) gave the Copper (Supplement) group a baseline to be compared against.

Groups ran in parallel: each of the participants stayed in one arm throughout.

This was a phase-I, randomized parallel three arms, double-blinded, and a placebo-controlled clinical trial.

The secondary endpoint was its effect on vital functions, anthropometrics, and laboratory tests.

The researchers used an exploratory approach by covariance analysis (ANCOVA) adjusted for the variables' baseline value for the secondary outcomes.

What Was Measured

PubMed files the paper under topics including Citrus, Dietary Supplements, Flavonoids, Glucosinolates, Menopause, Phytosterols and Plant Preparations.

The authors tagged it with the keywords Herbal supplement, adult women, citrus flavonoids, safety and tolerability.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Copper (Supplement) in 55 participants.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2021 (Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology), a journal based in England.

More context: the Copper (Supplement) compound page, all human trials.