Nutraceuticals World, January/February 2003

European Science on Proprietary Soy Products

Historically soy foods have been used in Asia for thousands of years and are regarded as healthy and safe. In Western Europe soy preparations are used mostly for their health benefits for people with lactose allergies or in specialized formulations.

Internationally, soy products are booming based on the international health claims, released first in the US by the FDA in 1999 and more recently in Europe by the UK based JHCI (Joint Health Claim Initiative).

Most soy research is based on the use of generic isolated soy protein in different preparations. Product specific studies are very rare.

In Europe there has been a movement over the last 20 years, looking into soy and its different compounds, to develop a proprietary patent protected line of products, which are now marketed internationally. The basis of this research has been to improve product effectiveness by combining different soy fractions and to patent these compositions. The main compounds are isolated soy protein containing isoflavones, soy cotyledon fiber and soy phospholipids. These patents are based on the research of Dr. Lars H. Høie, the founder of the company Nutri Pharma, listed on the Oslo stock exchange.

The first product was developed for weight loss and delivered excellent results in the following parameters: weight loss, cholesterol lowering, blood pressure lowering, and improvement of type 2 diabetes. This led to the marketing of a VLED product, called Nutrilett®, which has been very successfully sold in Scandinavia since 1989 by Nycomed Pharma. Over 20 clinical trials were performed with this product, many of them were randomized control trials showing a very substantial weight loss. For example, after eight weeks of VLED a mean weight loss of about 13 kg was observed. Long-term studies confirmed that after termination of the soy diet treatment, the weight reduction result remained. When different calorie levels were compared, VLED products at 420 kcal/per day and 530 kcal/per day with the LED product of 880 kcal/per day, given for the first six weeks of the study, followed by a hypo-caloric diet of 1600 kcal/per day, the authors of the study concluded that the three diets were equally effective in reducing body weight when used as the initial phase of a long-term weight reduction program.

Special studies were performed on patients with eating disorders and in people trying to quit smoking. In all cases impressive, significant improvements were found, compared to the control groups.

Based on excellent scientific data, a license was given to Numico/GNC in the US and Mayne Health/Faulding in Australia, leading to significant market successes in both markets.

In addition to the weight loss products, a number of functional food products and dietary supplements were developed for hypercholesterolemia and type 2 diabetes. These products have also been patent protected. The cholesterol lowering product Abacor® was investigated in six placebo controlled, randomized studies, showing total cholesterol and LDL cholesterol lowering effects of up to 20 %. In addition there were improvements in triglycerides and HDL/LDL ratios as well apolipoprotein B and homocystein levels, indicating clear superiority compared to other natural lipid lowering products such as stanols/sterols, betaglucan, omega-3-fatty acids, garlic, etc. Further research into the development of arteriosclerosis could show that Abacor® prevents the influx of oxidized LDL in the vascular wall and thereby reducing the development of arteriosclerosis.

Combination trials were performed with statins, the most prescribed drugs for cholesterol lowering, because the statins are partially not well tolerated and are associated with potential side effects. The reduction in statin treatment, using nutritional approaches, would improve the risk benefit ratio for these patients. A recently concluded study combining statins with Abacor® showed both total and LDL cholesterol were significantly reduced, a greater reduction than statin treatment alone. Abacor® can be integrated into different food forms such as bars, breakfast cereals, bread, yogurt, milk based drinks, fruit juices and other healthy beverages, or it can take the form of a dietary supplement in an individual sachet or concentrated drink form.

Scandinavia plays a special role in the development of functional food compounds such as stanols and sterols. The knowledge of soy health benefits has been greatly influenced by the active research on proprietary soy compounds, developed in Scandinavia. The number of proprietary protected soy products is limited, but offers a good opportunity for differentiation from generically isolated soy protein and has shown to clearly be more effective than generic soy protein products alone.