LDL-cholesterol lowering effect of a new dietary supplement: an open label, controlled, randomized, cross-over clinical trial in patients with mild-to-moderate hypercholesterolemia.

What Was Tested

This randomized controlled trial looks at Copper (Supplement).

The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid, named Argicolina (A), compared to a commercially available product containing monacolin K and coenzyme Q10, Normolip 5 (N).

Why It Was Studied

Hypercholesterolemia is a major risk factor for cardiovascular disorders and requires specific intervention through an adequate lifestyle (diet and physical exercise) and, if necessary, an appropriate drug treatment.

A growing attention has been devoted to the correction of dyslipidemias through the use of dietary supplements.

Who Took Part

PubMed indexes the participants as teenagers, adults, middle-aged adults and older adults, both men and women.

Evaluated parameters were: Total cholesterol (Tot-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglycerides (TG), fasting blood glucose, aspartate aminotransferase, alanine aminotransferase, creatinekinase, gamma-glutamyl-transpeptidase, brachial arterial pressure and heart rate, measured at the start and at the end of each treatment period.

How the Study Was Run

The design is described as randomized, open-label and crossover.

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

Nothing was hidden in this open-label Copper (Supplement) study: the participants and staff both knew the treatment.

Each person switched between Copper (Supplement) and the comparison at some point, usually with a gap in between.

Safety was monitored through the study.

What Was Measured

PubMed files the paper under topics including Analysis of Variance, Anticholesteremic Agents, Arginine, Ascorbic Acid, Cholesterol, HDL, Cholesterol, LDL and Dietary Supplements.

The authors tagged it with the keywords Hypercholesterolemia, LDL-cholesterol (LDL-C), Monacolin K, Red reast rice and Triglycerides.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Copper (Supplement).

Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (Lipids in health and disease), a journal based in England.

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