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Final development, clinical validation and launch preparation of NL01, an innovative health ingredient for supplements, food products and foods for special medical purposes

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Nutrition with evidence-based immune function

Researchers have responded to the increased demand for better nutrition in food products, with a health ingredient clinically proven to support immune function and well-being.

Food and Natural Resources

People want to live a long and healthy life and there is a huge demand for food products that enable immune function and increase resistance to infections. Additionally, not only do food products have to be natural, wholesome and nourishing, they must also have a positive impact on health, all without compromising taste and texture or ease of consumption. The EU-funded NUTRI-NEED project set out to develop the Xtramune™ food ingredient targeting food products used by young adults, adults and the elderly for their nutritional and immune function needs. Team members conducted a clinical study to test the efficacy of the product and to scale up the production process for the product. Having collected preclinical data and proven the ingredient safe in humans, the work puts coordinating company NutriLeads on track to become the first to launch an ingredient with an approved health claim for supporting immune function and increasing infection resistance.

Filling a gap for evidence-based nutrition

“NUTRI-NEED has a specific focus on delivering science-proven health claims for its ingredients. This will allow it to stand out and truly differentiate in the market and towards its stakeholders,” remarks Ruud Albers, CEO of NutriLeads. Strikingly, none of the currently marketed food products are sufficiently backed by convincing evidence, leading the European Food Safety Authority (EFSA) to reject claims of immune support for functional foods, including those for market-leading prebiotic and probiotic products.

Xtramune product development

NUTRI-NEED collaborated with a toll manufacturer to upscale the production of the Xtramune™ food ingredient and produced five core batches for quality assurance purposes. The project registered the Xtramune™ brand name, completed four patent applications and published two scientific papers as well. Researchers conducted a clinical trial to determine the effectiveness of Xtramune™ in a susceptible population of over 65-year-olds. These vulnerable older subjects consumed the health ingredient or a placebo over a 6-month period. The researchers found that Xtramune™ supports immune function and increases resistance to a respiratory infection in healthy subjects with a common cold virus. The team obtained and published the safety data needed to obtain market access in the United States and to file a Novel Foods dossier for evaluation by the EFSA (EFSA-Q-2020-00186). Having initiated these regulatory processes, the project can now seek out partners for production and commercialisation across the globe.

Future development plans

“We are seeking to obtain additional funding such as an EIC Accelerator grant to perform high-risk activities to accelerate and maximise the market uptake of our lead ingredient,” Albers concludes. “This will enable us to secure Xtramune’s health claim approval through completion of two human studies, and to implement a sustainable production process by using Xtramune’s side-stream waste.”

Keywords

NUTRI-NEED, Xtramune, immune function, food products, nutrition, health claim

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