"This is a big step for WellGen and a major step for bringing nutrigenomics into mainstream product development in the food and beverage industry," said Dr. Kathleen P. Mullinix, WellGen CEO. "We have completed the loop that validates WellGen's discovery process, and now we are moving toward commercializing our first functional ingredient for food applications," . The emerging field of nutrigenomics looks at how food bioactives can modulate gene expression in humans and potentially ward off particular diseases or conditions. According to the company, a recently completed double-blind randomized human study using the proprietary ingredient, WG0401, resulted in a two- to six-fold reduction in markers for inflammation when healthy volunteers were given an inflammation-inducing bacterial lipopolysaccharide. Chronic inflammation, brought about by an over-expression or lack of control of the normal protective mechanism, can lead to a range of inflammatory related disease, particularly cardiovascular disease, a leading cause of death worldwide. In a statement, WellGen said the results vindicated its approach of using cell cultures containing specifically targeted genes to determine that a plant or food extract could positively affect the same gene expression profile in humans. NutraIngredients-USA.com has not seen the full results of the study, and no one from WellGen was available prior to publication to confirm if the results had been submitted for publication in a peer-review journal. "The fundamental principle of nutrigenomics is that food ingredients can control the expression of genes that determine human wellness or disease," said Mullinix. "Our study has shown that WellGen's methodology is valid for discovering natural substances that can positively affect human health through gene expression." Moreover, the human study of WG0401 is also reported to have shown that the black tea extract may also have benefits for modulating the host's immune system. "WG0401, a food ingredient that is derived from black tea and is characterized by an enriched theaflavin content, will be available commercially this year," said a statement from the company. WellGen was spun off from Rutgers University in 1997 and in 1999 CEO Dr David Evans became the first employee. Dr Mullinix succeeded Dr David Evans, who passed away suddenly in June 2006. Based in New Brunswick, NJ, the biotechnology company screens the effect of food substances on gene expression associated with human health conditions.