Efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome: A double-blind, randomized, placebo-controlled trial.

What Was Tested

Researchers studied Copper (Supplement) in this randomized controlled trial publication.

Who Took Part

The study group was 56 patients.

The researchers randomly assigned 56 patients with IBS or IBS/FD to an intervention group (Group 1) or control group (Group 2) that were given supplement or placebo, respectively, in addition to the standard treatment regimen for 30 d.

Three outpatient visits were conducted during the study.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Copper (Supplement) and who got the comparison, which limits bias.

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

The comparison arm used a placebo, so changes seen with Copper (Supplement) could be set against what happens without it.

A double-blind, randomized, placebo-controlled trial.

Symptom severity was measured at each visit using a 7×7 questionnaire.

Qualitative and quantitative composition of the intestinal microbiota were assessed at visits 1 and 3 based on 16S rRNA gene sequencing.

What Was Measured

The subject headings attached to it are Catechols, Dietary Supplements, Dyspepsia, Fatty Alcohols, Irritable Bowel Syndrome, Limonene and Menthol.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Copper (Supplement) in 56 patients.

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 2022 (PloS one), a journal based in United States.

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