Periodic Reporting for period 2 - New Gluten World (A Revolutionary, Safe and Cost-effective Industrial Process for Gluten Detoxification in Cereals)
Reporting period: 2017-11-01 to 2018-10-31
Wheat, barley, and rye are leading crops in the worldwide agro-food system. These cereals contain gluten, a valuable protein for both the milling and food industry, due to its unique organoleptic and technological properties. Gluten gives dough its viscoelasticity, and allows for leavening.
However, for people suffering from celiac disease, gluten triggers an autoimmune reaction, causing inflammatory symptoms, destruction of intestinal villi and malabsorption of nutrients. Celiac disease affects 1% percent of the global population, an estimated 70 million people. Furthermore, one third of humanity carries genetic markers that put them at risk of developing the disease.
New Gluten World (NGW) has devised a revolutionary, safe and cost-effective industrial process that turns gluten of cereal grains into a bioactive protein that become easily digestible by human gut microbiota, able to produce positive effects on human health . The method is the result of an advanced biotech research project from the University of Foggia, led by the inventor, Professor Carmela Lamacchia.
NGW’s patented technology, called Gluten Friendly™, will replace the current market approach to celiac consumers, which is focused on designing “gluten free” substitutes, or detoxifying flours with expensive enzymes. This will create a radical shift of paradigm in the milling industry. The Gluten Friendly™ technology is based on a natural, physical-chemical process that reshapes gluten, directly inside the kernel. The temperature-based process maintains all the nutritional, sensorial and mechanical properties of gluten intact.
The Gluten Friendly™ technology will become an engine of social innovation because it will tear down the “Nutritional Divide” that separates people with celiac disease from healthy individuals. In Europe and around the world, celiac disease presents a major social and economic challenge. NGW will tackle that challenge by providing celiac consumers with a safe and more affordable option than a “gluten free” diet. Furthermore, NGW’s gluten temperature-based technology provides a healthy new choice for healthy people, those with gluten sensitivities and for the one third of humanity that carries genetic markers that put them at risk of developing the celiac disease.
Finally, it introduces a new production standard in the milling industry.
The NGW team, comprised of industrial and technological experts, offers milling companies (mostly SMEs) in Europe and around the world, the opportunity to license the gluten temperature-based technology. Through the licensing program, NGW provide SMEs with the necessary know-how to achieve gluten temperature-based technology in cereal grains, as well as rules and guidelines. Thus, reinforcing the leadership of the European agro-food industry, in terms of quality, as opposed to intensive agro-food models from other economic systems.
The market opportunity is enormous, and it is fenced by a patent that extends to 104 countries. NGW has moved from TRL #6 to TRL #8 and #9 in a 24-month time-span. NGW aims at becoming the market leader for industrial, gluten temperature-based process in cereals across all markets – including flours, baked products, pasta, ice-creams, and beer. NGW plans to reach a turnover of more than €100 million by 2023, with an ambitious hiring plan of qualified workers across Europe.
However, for people suffering from celiac disease, gluten triggers an autoimmune reaction, causing inflammatory symptoms, destruction of intestinal villi and malabsorption of nutrients. Celiac disease affects 1% percent of the global population, an estimated 70 million people. Furthermore, one third of humanity carries genetic markers that put them at risk of developing the disease.
New Gluten World (NGW) has devised a revolutionary, safe and cost-effective industrial process that turns gluten of cereal grains into a bioactive protein that become easily digestible by human gut microbiota, able to produce positive effects on human health . The method is the result of an advanced biotech research project from the University of Foggia, led by the inventor, Professor Carmela Lamacchia.
NGW’s patented technology, called Gluten Friendly™, will replace the current market approach to celiac consumers, which is focused on designing “gluten free” substitutes, or detoxifying flours with expensive enzymes. This will create a radical shift of paradigm in the milling industry. The Gluten Friendly™ technology is based on a natural, physical-chemical process that reshapes gluten, directly inside the kernel. The temperature-based process maintains all the nutritional, sensorial and mechanical properties of gluten intact.
The Gluten Friendly™ technology will become an engine of social innovation because it will tear down the “Nutritional Divide” that separates people with celiac disease from healthy individuals. In Europe and around the world, celiac disease presents a major social and economic challenge. NGW will tackle that challenge by providing celiac consumers with a safe and more affordable option than a “gluten free” diet. Furthermore, NGW’s gluten temperature-based technology provides a healthy new choice for healthy people, those with gluten sensitivities and for the one third of humanity that carries genetic markers that put them at risk of developing the celiac disease.
Finally, it introduces a new production standard in the milling industry.
The NGW team, comprised of industrial and technological experts, offers milling companies (mostly SMEs) in Europe and around the world, the opportunity to license the gluten temperature-based technology. Through the licensing program, NGW provide SMEs with the necessary know-how to achieve gluten temperature-based technology in cereal grains, as well as rules and guidelines. Thus, reinforcing the leadership of the European agro-food industry, in terms of quality, as opposed to intensive agro-food models from other economic systems.
The market opportunity is enormous, and it is fenced by a patent that extends to 104 countries. NGW has moved from TRL #6 to TRL #8 and #9 in a 24-month time-span. NGW aims at becoming the market leader for industrial, gluten temperature-based process in cereals across all markets – including flours, baked products, pasta, ice-creams, and beer. NGW plans to reach a turnover of more than €100 million by 2023, with an ambitious hiring plan of qualified workers across Europe.
Activities carried out by NGW team during the two years project have been the following:
• Standardize the detoxification method
• Address technical solution for thermal issues and sample homogeneity
• Address technical solution for full portability
• Scale up the detoxification microwave oven
• Address material and assembly technical fine tuning
• Design the final prototype
• Build up the final prototype
• Validate the final prototype by R5 ELISA on wheat Gluten Friendly™ flour and G12 ELISA on in vitro digested Gluten Friendly™ bread
• Validate the safety and efficacy of the Gluten Friendly™ bread by studying the effect in vitro on HT29 – Human Colon Epithelial Cells
• Validate the safety and efficacy of the detoxified Gluten Friendly™ bread by an in vitro fermentation study on the effects on microbiota and short chain fatty acids of fecal samples from healthy and celiac subjects
• Set up the in vivo study as a prospective, double-blind, placebo-controlled, randomized trial on either young (15 years old) and adult patients with biopsy-proven CD to validate the safety and efficacy of the Gluten Friendly™ in vivo.
• Evaluation of the effects of the Gluten Friendly™ products on the state of health and illness of celiac patients by verification of their clinical and bioumoral indices and symptoms, in the acute phase, and on the integrity of their intestinal mucosa, in the chronic phase.
• Evaluation of the effects of the Gluten Friendly ™ products on the celiac patients gut microflora
• Evaluation of the effects of the Gluten Friendly™ products on the presence of 33-mer in celiac patients stools.
• Evaluation of the effects of the Gluten Friendly™ products on celiac patients intestinal permeability.
During the project, communication and dissemination activities have been implemented through our website, our social media channels, video, scientific publication, non-scientific articles, participation at conferences and events.
• Standardize the detoxification method
• Address technical solution for thermal issues and sample homogeneity
• Address technical solution for full portability
• Scale up the detoxification microwave oven
• Address material and assembly technical fine tuning
• Design the final prototype
• Build up the final prototype
• Validate the final prototype by R5 ELISA on wheat Gluten Friendly™ flour and G12 ELISA on in vitro digested Gluten Friendly™ bread
• Validate the safety and efficacy of the Gluten Friendly™ bread by studying the effect in vitro on HT29 – Human Colon Epithelial Cells
• Validate the safety and efficacy of the detoxified Gluten Friendly™ bread by an in vitro fermentation study on the effects on microbiota and short chain fatty acids of fecal samples from healthy and celiac subjects
• Set up the in vivo study as a prospective, double-blind, placebo-controlled, randomized trial on either young (15 years old) and adult patients with biopsy-proven CD to validate the safety and efficacy of the Gluten Friendly™ in vivo.
• Evaluation of the effects of the Gluten Friendly™ products on the state of health and illness of celiac patients by verification of their clinical and bioumoral indices and symptoms, in the acute phase, and on the integrity of their intestinal mucosa, in the chronic phase.
• Evaluation of the effects of the Gluten Friendly ™ products on the celiac patients gut microflora
• Evaluation of the effects of the Gluten Friendly™ products on the presence of 33-mer in celiac patients stools.
• Evaluation of the effects of the Gluten Friendly™ products on celiac patients intestinal permeability.
During the project, communication and dissemination activities have been implemented through our website, our social media channels, video, scientific publication, non-scientific articles, participation at conferences and events.
New Gluten World wants to introduce the revolutionary Gluten Friendly™ methodology on international market; a new and innovative temperature-based method that turns gluten of cereal grains into a bioactive protein that become easily digestible by human gut microbiota, able to produce positive effects on human health. Celiac people and subjects with gluten sensitivity are the potential direct users of the Gluten Friendly™ technology. This level of the market is extremely competitive and very sensitive to innovation, (in comparison to downstream vertically integrated markets). NGW would like to present how the Gluten Friendly™ technology is instrumental to strategies of differentiation in a cost-effective and efficient way. The Gluten Friendly™ industrial process is marginally inexpensive for milling companies, when compared to traditional pasta-making, and is also significantly more convenient than gluten-free food production. Furthermore, the implementation of the Gluten Friendly™ technology inside milling plants will be easy and power-efficient. The goal for the Gluten Friendly™ flour is to become the standard, not only for people with gluten sensitivity, but also for healthy individuals. Thus, replacing traditional flour in daily diets for all. NGW aims at becoming a worldwide market leader for gluten detoxification, with a turnover of over 100M€ by 2023. NGW will develop final industrial prototypes after a cautious scale-up and indepth marketing activities. EBITDA ratio is expected to reach 59% in 2023, as a result of the business model chosen by NGW, to bring its technological solution to the market with a Worldwide Licensing Program.