The EU FibeBiotics project has announced two events that it says indicate the progress of the consortium.
The project studies the effect of non-digestible polysaccharides (NPS) on the gut and immune system of humans. The project started in January 2012 and will last for 4.5 years, receiving a EU support of €6m.
The first announcement is the start of the first human pilot trial. The trial design is a randomised double blind placebo controlled trial with six arms in which 240 (40 in each arm) elderly subjects (>50 years) will receive a food intervention of five weeks. The five NPS included in this study are 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.
After a wash out period and two weeks of intervention, the subjects will receive a standard flu vaccination. Subsequently, one and three weeks after the vaccination, blood and faeces will be sampled to analyse the effect of the intervention. These analyses focus on 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 first months of the project were already very intense,” said the coordinator, Jurriaan Mes of Food & Biobased Research of Wageningen UR. “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.”
The clinical trial is organised by one of the FibeBiotics partners, Clinical Research Centre (CRC) in Kiel.
“This pilot study should teach us what NPS compounds are interesting 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 interesting to include in such a large study,” said Christiane Laue, CEO of CRC.
The second important milestone of the FibeBiotics project was the first Industrial Platform meeting that was held in Ghent, October 4th. 22 members of the Industrial Platform (including some of the largest food and beverage companies in Europe) were present and learned about the goals and approaches of the FibeBiotics project. The members were said to be enthusiastic about the approach and very eager to be involved in future steps. The Industrial Platform members also visited the facilities of one of the FibeBiotics partners, ProDigest.
The Industrial Platform of FibeBiotics is open to new interested industrial stakeholders.
FibeBiotics has enlisted four European universities, five research institutes, and eight companies – among them suppliers of the key ingredients used in the clinical studies – in a team effort 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 consortium said, 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.
