Randomised, double-blind, placebo controlled phase II study of the efficacy of Phospha-E biomarkers of inflammation, in patients with metabolic syndrome and mild to moderate hyperlipidemia.

The study is for subjects who have a condition called metabolic syndrome. Metabolic syndrome is a condition in which people may have a number of clinically determined symptoms such as abdominal obesity, high cholesterol (lipid) and glucose levels in the blood and high blood pressure, as well as others. Some people may have only some of these clinical symptoms while others may have more. These clinical observations, and the severity of them, are recognised in a number of well known disease states such as cardiovascular disease and diabetes. Vitamin E has been around for decades and is widely used by people for its known antioxidant properties. D-alpha Tocopheryl Phosphate (Phospha-E™) has recently been discovered to be naturally occurring in the body (like vitamin E) and has shown promising effects in laboratory studies on inflammatory markers which are implicated in a number of disease states associated with a condition known as Metabolic Syndrome. The purpose of this study is to see if D-alpha Tocopheryl Phosphate (Phospha-E™) has any effect on your metabolic syndrome. The study would like to determine if D-alpha Tocopheryl Phosphate (Phospha-E™) is able to lower biomarkers such as cholesterol and various inflammatory markers, compared with placebo, a capsule that looks the same as D-alpha Tocopheryl Phosphate (Phospha-E™) but has no active ingredient. These biomarkers are important factors that contribute to the development of metabolic syndrome It is not known whether D-alpha Tocopheryl Phosphate (Phospha-E™) is better than receiving no drug or receiving classical vitamin E, and this is what is to be determined. The study will compare two different doses of the study drug, D-alpha Tocopheryl Phosphate (Phospha-E™) to placebo (an inactive look alike capsule). It will also compare classical vitamin E to placebo.