The Proof is in the … Clinical Trial

A few days ago (May 25), I deliberately used a quite clumsy run-on sentence to describe a clinical trial: “Just this month (May 2007), the results of a sizeable (120 women aged 25 to 50), 12- week, randomized, double-blind, placebo-controlled clinical study on FloraGLO Lutein was published in the journal of Skin Pharmacology and Physiology.”



My point was that every aspect of the study design increased its probative power. It was a “clinical trial” meaning that results were measured rather than observed or reported. The study was “sizeable”. In other words, the results could not easily be attributed to chance. The study was long enough to achieve measurable results.



The treatments (lutein supplement, topical lutein, topical and oral lutein, or placebo) were allocated to subjects randomly to assure that the different treatment groups were statistically equivalent. This study was also double-blind, meaning neither the subjects nor the researchers knew which subjects were receiving which treatments – until it came time to tally the results.



Finally this study included placebos so that researchers could gauge and discount the placebo effect. It is well-known that if a subject expects a new treatment to work, there will be some improvement even if that particular subject is given a placebo (an inactive pill or cream that has no treatment value).



This is the type of study I search for when I evaluate new cosmeceutical or nutraceutical ingredients. More on the placebo effect, contaminated results and web forum testimonials next time …



Tags: Lutein supplements, anti-aging vitamins, Lutein for skin & joints