The trial will establish the efficacy of Phospha E in the management of metabolic syndrome, which is becoming an increasing problem worldwide. Ingredients which have a track record of clinical trials to support their efficacy in this field, will become more important as Europe is set to face an explosion in metabolic syndrome. The Australian firm Phosphagenics said yesterday that "ethics approval" has been obtained to conduct the double-blind phase clinical trial, which will commence "shortly." The syndrome is a collection of health conditions, including fat around the waistline, high blood pressure, insulin resistance and low HDL cholesterol, which taken together, significantly increase the risk of type 2 diabetes and heart disease. An estimated 15 per cent of the European adult population already have this combination of obesity-related conditions, and figures on childhood obesity suggest that Europe could follow the US trend for rising metabolic syndrome among the younger generation. In the US, incidence of metabolic syndrome has risen dramatically in the past 10 years and now affects up to 32 per cent of adults, an estimated 50 million people. Recent studies suggest that two million US adolescents - one third of all overweight youngsters - were also affected, compared with just under one million estimated less than a decade earlier, according to the International Obesity Task Force. Dr. Esra Ogru, executive vice president research and development at Phosphagenics, said: "It is very rewarding to see Phospha E progress down the clinical trial path after years of pre-clinical testing. We have reached a very exciting stage of the development of this product and are delighted to be aligned with the world's largest nutrition company as our partner." Nestle will fund the clinical trial and will be granted a worldwide exclusive license for the use of Phospha E in medical foods, while Phosphagenics will manufacture and supply Phospha E to Nestle. The final commercial arrangements are expected to be completed by the end of this year. This collaboration builds upon two pre-clinical dose response trials performed by Nestle and Phosphagenics in 2006. The results of these trials suggested that when given orally Phospha E significantly reduced many of the key biomarkers associated with metabolic syndrome, inflammation and cardiovascular disease, Phosphagenics said. In January 2007 the Australian-based Phosphagenics entered into an agreement with Nestlé for the firm to licence the product for use in nutritional products aimed at metabolic syndrome. In July Nestlé and Phosphagenics extended the deadline for concluding their agreement for the use of Phospha E in foods while the Swiss firm incorporates Novartis Medical Nutrition into its portfolio. Novartis will help increase Phospha E's availability on the market, Nestle said. Phospha E is a patented derivative of vitamin E that is said to have superior properties compared to its parent molecule. Phosphagenics said it has been shown to be better absorbed than vitamin E, both orally and through the skin, to lower cholesterol and triglycerides, prevent the formation of plaque in heart arteries, as well as having unique anti-inflammatory properties. Phospha E is currently sold internationally as a dietary supplement by NBTY Inc. under the name of Ester-E and is marketed worldwide in the personal care market as Vital ET by ISP Corporation.