Taking on Age-related Macular Degeneration

Scientific collaboration supports entrepreneur Newtricious in the battle against elderly blindness

Within the Netherlands, a successful collaboration between Maastricht University and biotech company, Newtricious, has provided a leap forward in protecting the elderly against a serious eye condition. This condition, which affects a large group of seniors all over the world, is called Age-related Macular Degeneration (AMD). AMD is a serious eye disorder for which there is as yet no treatment. This disease has a great impact on people’s well-being because it reduces the vision drastically and can even lead to blindness.

By connecting the right parties, a successful consortium emerged between two large research institutes and Newtricious, a small enterprise. Within the project, several research institutes, small/medium-sized enterprises (SMEs), and large companies were carefully selected to participate on different aspects of the project. Thanks to the innovative climate in the Netherlands, which is supported by extensive governmental programs, the project is now moving towards its commercialization phase.

Cross section of the eye (with macula lutae)

Age-related Macular Degeneration: Reducing the quality of life of our elderly population

As a result of Age-related Macular Degeneration (AMD), a dark, blurred spot develops in the center of vision that, among other things, severely impedes recognition of faces and eliminates the ability to drive. The affected age group consequently suffers from a significant reduction in quality of life.

In Europe alone, 5.5 million people have been diagnosed with AMD. Most probably, approximately 62 million additional people are at risk of developing AMD, or are in the early stages of the disease without even knowing it. The condition usually occurs from age 55 onwards, with almost 50% of people aged 65 and above suffering from this disease in a range from mild to very serious. Due to the progressive ageing of the population, the number of those affected will further increase.

Normal vision

Vision of AMD patient

As mentioned above, AMD has a very large impact on the quality of life. A recent study indicates that even a mild form of AMD reduces the quality of life by 17%: comparable to the impact of angina pectoris. The final stage of AMD causes a 63% decline in quality of life, which is comparable to conditions such as end-stage prostate cancer or a massive heart attack.

Both observational and interventional studies indicate that lutein and zeaxanthin may protect against the development of AMD. These two carotenoids are the main constituents of the yellow pigment in the macula and play an important role in protecting the retina against damage from energy-rich fractions of incoming light. The macular pigment filters blue light and is a powerful antioxidant needed in an environment with very high local oxygen concentrations. An accumulation of photo-oxidated retinal lipids and protein in the macula is considered to be the initial trigger leading to AMD. Adequate amounts of the macular pigment are, therefore, expected to guard against the development of AMD.

It has been proven that the macular pigment in the eye increases due to an elevated intake of lutein and/or zeaxanthin. The human body doesn’t produce these carotenoids by itself, and dietary intake is low. They occur naturally in corn and leafy green vegetables (such as broccoli and spinach), but today are also an ingredient of a large variety of commercially available food supplements. However, carotenoids are fat-soluble, and bioavailability is low due to the low-fat environment in vegetables and food supplements.

Eggs are also a source of lutein and zeaxanthin, since their levels are dependent on the diet of the chickens. The fatty composition of the yolk binds the fat-soluble carotenoids, thereby causing a very efficient absorption in the human body.

Origins of the Macula project

Dr. T.T.J.M. Berendschot, a renowned eye scientist at the University Eye Clinic Maastricht, has done many trials to understand AMD and other eye disorders. Newtricious, a young SME, develops functional foods and has expertise in egg science. Since the egg yolk is an excellent carrier of carotenoids, the eye scientists at Maastricht and representatives of Newtricious realized, after brainstorming about cooperative possibilities, that they shared a strong common interest in this field of study.

In 2007, a study was initiated in the framework of the Innovation Programme Food & Nutrition Delta, in which carotenoid-enriched eggs were supplied to healthy volunteers to investigate the effect of these eggs on macular pigment density, and to study whether or not this could ultimately lead to an improvement in the visual function of patients with AMD.

After initial studies into the field of natural sources of lutein and zeaxanthin, enriched animal feeds, and stability and consistency of carotenoid levels in the hen eggs, the first trial in human volunteers was conducted in 2007. This trial was performed at the University Eye Clinic Maastricht. The Human Biology department of Maastricht University also joined the investigations by monitoring other effects on the body besides eye function, such as cholesterol levels and risk factors for cardiovascular diseases. In this pilot study, there were strong indications that the quantity of lutein in the eye increased in the test group that ate carotenoid-enriched eggs.

Current developments: Building a dossier in a climate of tightening legislation

The goal of the project is to make the enriched eggs commercially available to AMD patients and people that are at risk of developing AMD. In order to reach this group of consumers, a health claim provides the strongest opportunity for communicating the added value of the enriched eggs.

Both in Europe and the United States, new food legislation is a hot topic. The implementation of article 13 in EFSA’s Regulation 1924/2006 sweeps the shelves of supermarkets clean of unfounded claims. The FDA and other worldwide regulatory authorities, although not fully harmonized with EFSA, tend to apply similar principles.

In order to comply with current and future legislation, the consortium started at the end of 2009 a prolonged study in individuals with early signs of AMD. This study will continue until mid-2011 and, again, will be carried out by the departments of Ophthalmology and Human Biology at Maastricht University. In this placebo-controlled clinical trial, 100 volunteers consume the enriched eggs for a year, while being monitored on a large number of different visual functions, and risk factors for cardiovascular disease. The desired outcome is a significant reduction in the progression of AMD, up to the point of stability of the disorder. With these outcomes, people at risk of developing AMD would have a powerful option to prevent further degeneration.

The consortium: Collaborating and connecting

Newtricious and Maastricht University have signed a collaboration agreement regarding joint research on AMD, including a statement on reinvestment of profits from exploitation into follow-up studies.

This collaboration enables Newtricious to keep working with a prominent scientific party on the frontline, which is important for further substantiation of the health claim. Apart from commercial opportunities, it also demonstrates the involvement with patients and the search for prevention and treatment of this important eye disease.

In the development of this enriched egg, many other parties have collaborated: from research on the chicken feed, and the source of carotenoids in flowers done by specialists from Wageningen University and Research Centre (WUR), to several experts on behalf of the end consumer.

The positive innovation climate created by the Dutch government with both national and European funds makes it interesting for all types of partners to join in on innovative, high-risk projects. The project started with the financial support of the Food & Nutrition Delta, and is currently supported by the OP-Zuid Programme, a joint funding from Dutch provinces, cities and the European Union.

From this angle, the prestigious Food Valley Award that Newtricious was awarded in 2008, is also a tribute to its collaborating partners. The award is annually presented to the food industry’s most distinctive initiative in terms of innovation, cooperation, and corporate social responsibility. This further encourages Newtricious and the scientists at Maastricht to carry on this challenging project.

Contact Details:
For further information, please contact
Lieke van Adrichem, Project Manager, Newtricious.
lieke.van.adrichem@newtricious.nl
Telephone: +31 478 578702

For additional information visit the Newtricious website
www.newtricious.nl