A softgel dietary supplement containing esterified plant sterols and stanols improves the blood lipid profile of adults with primary hypercholesterolemia: a randomized, double-blind, placebo-controlled replication study.

What Was Tested

The paper reports a study of Phytosterols, published as a randomized controlled trial.

The purpose of this randomized, double blind, placebo-controlled crossover study (conducted July 2011 to January 2012) was to support these previous findings in a similar, but independent, sample with a different lead investigator and research site.

Repeated measures analysis of covariance was used to compare outcomes for sterol/stanol and placebo treatment conditions using the baseline value as a covariate.

Who Took Part

According to the abstract, 8 men were involved.

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, both men and women.

Forty-nine subjects were screened and 30 (8 men and 22 women) were randomized to treatment (all completed the trial).

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and crossover study.

Random assignment meant chance, not the researchers, decided who got Phytosterols and who got the comparison, which limits bias.

Neither the men nor the staff measuring them knew who was on Phytosterols, so expectations could not easily colour the readings.

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

Each person switched between Phytosterols and the comparison at some point, usually with a gap in between.

What Was Measured

Topics PubMed links to this paper include Cholesterol, Cholesterol, HDL, Cholesterol, LDL, Diet, Dietary Supplements, Esterification and Hypercholesterolemia.

Author keywords: Low-density lipoprotein cholesterol, Phytostanols and Phytosterols.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Phytosterols in 8 men.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2014 (Journal of the Academy of Nutrition and Dietetics), a journal based in United States.

More context: all human trials.