The data will be analysed using, “many biomarkers including those indicative for the innate immune system, the adaptive immune system, the effect on gut microbiota and metabolites generated by the gut microbiota as a response to the intervention.”
The trial involes Wellmune yeast beta-glucan, OatWell oat beta-glucan, NAXUS wheat arabinoxylan, beta-glucan of Shiitake mushroom and a powder containing exopolysaccharides produced by Lactobacillus mucosae.
The trial is part of the FibeBiotics project that began in January, unites business and academia, has €6m in EU funding, and is set to complete in 2016. Non-digestible polysaccharides (NPS) are its core focus.
The project involves four European universities, five research institutes, and eight companies.
One of the partners, Clinical Research Centre (CRC) organised the current trial. CEO Christiane Laue said: “This pilot study should learn us what NPS compounds are interested to include in follow-up studies, directly learn what number of persons should be included in a pivotal trial to reach significant effects and what biomarkers are most interested to include in such a large study”.
FibeBiotics won funding over about 30 other project proposals because, in part, it has determined to mould its research around requirements under the EU nutrition and health claims regulation (NHCR) as published by the European Food Safety Authority (EFSA).
Project goals
Project chief, Jurriaan Mes, from the Food & Bio-based Research department of Wageningen University in the Netherlands said the project was taking shape after a “very intense” beginning.
“NPS compounds needed to be isolated, needed to be packed according to the double blind placebo controlled design, the ethical protocol had to be written, pilots for biomarkers analysis performed etc. But thanks to the collaborative action of the dedicated partners we managed everything in time,” Mes said.
The project seeks to, “standardise analytical methods, set up in vitro assays to support product development, study the mechanism of action, validate biomarkers and conduct clinical trials on non-digestible polysaccharides.”
This is the first large EU project where researchers work together with the industry and aim to develop end-products that might be able to pass EFSA claim evaluation and do this by using the EFSA guidelines in the area of gut and immune function. FibeBiotics beat out 30 other projects on bioactive compounds and functional products that were petitioned to the EU.