A pilot trial is now underway.
The first clinical trial in a €6 million EU immune health project is now underway.
Earlier this year, we reported on FibeBiotics, the multi-year EU-funded project that would employ four universities, five research institutes, and eight companies in an investigation of novel food ingredients with potential for supporting immune health-and maybe obtaining an EFSA health claim.
The pilot trial for the program is now underway, with 240 elderly subjects receiving one of five food interventions for five weeks: Wellmune yeast beta-glucan, OatWell oat beta-glucan, NAXUS wheat arabinoxylan, shiitake mushroom beta-glucan, or a powder containing exopolysaccharides from Lactobacillus mucosae. After two weeks of intervention, participants will receive flu vaccinations followed by blood and feces analysis at one and three weeks post-vaccination. These analyses will yield conclusions relating to activity of the innate immune system, the adaptive immune system, and microbial and metabolite profiles in the gut.
“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,” [sic] said Christiane Laue, CEO of Clinical Research Center Kiel GmbH, which is organizing the pilot trial.