Dutch R&D firm has AMD claim in its sights

By Lynda Searby

- Last updated on GMT

The trial could pave the way for a health claim related to AMD
The trial could pave the way for a health claim related to AMD
The results of a clinical trial confirming the bioavailability of dried lutein-enriched egg yolk bring Dutch biotech firm Newtricious a step closer to submitting a dossier for an article 14 or 13.5 age-related macular degeneration (AMD) claim in Europe.

Macuview, the company’s lutein-enhanced egg yolk product, is the most advanced in its R&D portfolio with four clinical trials completed and a fifth underway.

Previous research found consumption of fresh liquid lutein-enriched egg yolk increased plasma and macular levels of lutein. However, in its fresh form, lutein-enriched egg yolk only has a two to three week shelf life. This latest study, published in the International Journal of Food Sciences & Nutrition​, investigated whether a longer life dried form of the supplement exhibited the same functional properties.

100 healthy 18-25 year-olds participated in the randomised controlled study, conducted by researchers from Wageningen University. They consumed either a ‘plain’ control beverage, a fresh lutein-enriched egg yolk beverage, a dried version of this beverage, or a beverage composed of the dried individual components of the drink. The researchers found that both the fresh and dried versions of the beverage significantly increased serum lutein and zeaxanthin levels after six weeks’ intervention compared with the control drink.

Proof for practical powder format

Dr Luc Sterkman, COO of Newtricious, told NutraIngredients these results formed the basis for further development of Macuview in a powder formulation.

“The results have enhanced the commercial opportunity by avoiding the cold chain for distribution and increasing the shelf life,”​ he said.

The study also adds to Macuview’s growing body of evidence which the company believes is now almost complete enough to form the basis of a health claim dossier.

“Newtricious has completed an extensive development programme for Macuview, which includes five clinical trials targeting visual function, all performed according to pharmaceutical principles including Good Clinical Practice,”​ said Dr Sterkman.

He said a second multi-centre pivotal study involving 120 subjects was ongoing at universities in the USA, UK, Netherlands and Germany. The results of this study are expected to be available by mid 2015, completing the dossier for an article 13.5 or 14 proprietary data EU nutrition and health claims regulation (NHCR) submission to EFSA (European Food Safety Authority).

Whilst Dr Sterkman said it was too early to talk about specific wording, he said ideally, Newtricious would want the term “age-related macular degeneration”​ to be included.

Drawing on DHA data

In the interim, Newtricious is getting a head-start on commercialising Macuview using the article 13.1 generic claim “for maintenance of normal vision”​ that exists for DHA (docosahexaenoic acid).

It has been piloting Macuview in the Netherlands since the start of 2014, and Dr Sterkman confirmed that “uptake is good and repeat purchase is very high​”.

In its domestic market, Newtricious is working directly with independent opticians and chains, in what Dr Sterkman terms a “push and pull”​ strategy. Consumers already seem to be “pulling”,​ as the product is now also stocked in pharmacies in response to customer requests.

protein_powder_iStockfree

In contrast to other products targeting AMD, Newtricious has opted for a powder beverage format for the supplement.

“Other products on the market are in capsule or tablet format, but they tend to be fairly large and are difficult for seniors – our main target population – to swallow. Our specific delivery system also offers very consistent and higher absorption compared with capsules and tablets,” ​said Dr Sterkman.

He said the next step would be to launch into the US and other European countries and confirmed that Newtricious was already in discussion with major food and pharmaceutical companies as potential partners.

The commercialisation strategy would most likely vary from country to country, though, said Dr Sterkman.

“In the UK, for example, optometrists mainly work in high street practices so may be the ideal entry route to the market. In the US, on the other hand, awareness of AMD is a lot higher and people are already taking supplements, so the best route may be through a partnership with a powerful player.”

 

Source:

International Journal of Food Sciences & Nutrition

DOI: 10.3109/09637486.2014.937798

“Bioavailability of lutein from a lutein-enriched egg-yolk beverage and its dried re-suspended versions”

Authors: Meike Bunger, Miriam Quataert, Lisette Kamps, Pieter Versloot, Paul J. M. Hulshof, Arnoud Togtema, Aart van Amerongen, and Marco Mensink

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