08 Jun 2017 --- FrieslandCampina, NIZO and NutriLeads are joining forces in the Challenge consortium, which will aim to develop new food ingredients that will support resistance to infections, as well as affordable and predictive research models in healthy volunteers to allow companies accelerated market access.

“Infections of the upper airways and the gut are an important cause of morbidity and mortality worldwide. Medicines are not always the solution and can be expensive. Therefore, it would be of interest to study if components in food can help to increase the immune defense of humans against infections as preventive measure,” Marjolijn Bragt, Manager Nutritional Sciences at FrieslandCampina, tells NutritionInsight.

The results will benefit infants, young children and elderly in particular, but healthy adults could benefit from this too, Bragt says.

“FrieslandCampina wants to contribute towards feeding the world population and focuses on improving its products to contribute to the consumer needs. The innovative power of Challenge is expressed in the evaluation of translational biomarkers for infants and children,” she adds.

A spokesperson for NIZO noted how the company has developed human challenge models for determining how the human body can cope with such “challenges” to infection resistance. In these models, researchers apply moderate stresses, such as a vaccination or a gut or respiratory infection. These challenge studies include a control group and a group that receives potentially resistance boosting ingredients who are afterwards both exposed to an attenuated (i.e. debilitated) gut or respiratory pathogen.

“The aim of the consortium is to develop methods to be able to show and substantiate potential immune modulating effects of food and food components. To this end, in vitro immune assays and in vivo Challenge studies are included. In the Challenge studies, healthy human volunteers will be exposed to weakened bacteria, viruses or vaccines. It will be tested if food or food components can improve the immune response of the body upon this challenge,” Bragt notes.

Within the Challenge project NutriLeads will "perform a human trial to test the effect of its lead ingredient on resistance to common respiratory infections. The design of the trial will be based on a challenge model, more specifically a proven common cold infection model, in which trial volunteers will be challenged with a common cold virus to assess the protective effect of our food ingredient against this model infection,” Ruud Albers, CEO of NutriLeads, tells NutritionInsight.

Albers adds that the company “strongly believes in the Human Challenge Model concept" and that "the Challenge consortium is a logical next step in substantiating the immune supportive effect of our lead ingredient, a novel Immune Modulating Plant Polysaccharide.”

In terms of the active ingredients the consortium will be looking into, Bragt underlines that as a dairy cooperative with scientific expertise on the nourishing aspects of milk and its dairy chain, FrieslandCampina will focus on “dairy components that have the potential to improve the immune response.”

Speaking on the challenges current regulation poses in terms of the body of science required to prove the efficacy of active compounds, Albers notes that “within the current regulatory framework, it is important to demonstrate clinically relevant effects, biological plausibility and cause-effect relationships. Challenge models such as the common cold infection model that NutriLeads will use can help to do so within a controlled setting in a relevant human target population.”

Bragt adds: “To be able to make claims, thorough substantiation is needed and also requested by regulation. You have to build a scientific dossier with studies of the right quality and quantity, using the right methods, endpoints and biomarkers. This consortium enables us to build substantial evidence on the potential of dairy components to improve the immune response.”

According to Bragt, the Challenge model can be an important step to fill the gap between in vitro laboratory studies and large scale and expensive field studies in humans. This will eliminate the need for animal testing, a testing method Royal FrieslandCampina refrains from using.

According to Alwine Kardinaal, project leader at NIZO, “The combined research power of the companies involved is unique and will enable [the companies] to take the next step in predicting health benefits with the use of Human Challenge Studies. Especially in nutrition research, challenge studies are a unique approach to induce a physiological response in healthy subjects and to investigate how an active ingredient modulates this response. Given NIZO’s reputation with i.e. the ETEC model, we are confident to lead this exciting project.”

Both Bragt and Albers note that the companies will be testing their own products, but will be working closely together to assess the effects of different food components.

“We definitely aim for synergy in this consortium, by bundling knowledge and expertise to develop innovative methods to demonstrate the immune modulating properties of food components. In one of these models, we will test our own product. Based on the shared learnings from the partners, we can determine the predictive value of in vitro laboratory studies and in vivo Challenge studies to establish immune modulating effects of food components,” Bragt says.

“Within the project, NutriLeads will test its own functional ingredient, and together with NIZO and Friesland Campina, we will further develop and validate challenge models in humans to assess health effects of food ingredients and food products,” Albers concludes.

According to a press release issued by NIZO, the Challenge project has a total budget of €3.7 million (US$4.2 million), of which €1.5 million will be co-financed by the EU and EFRO OP-Oost. The subsidy was granted in Q2 2017; first results will become available later this year.

by Lucy Gun