Prof. J.G. Bindels (PhD) will contribute by channelling the expertise and facilities of Danone Research BV into the project. As a nutritionist with a biochemical background, and as a former professor of Nutrition during growth and development (Wageningen University, The Netherlands), combined with his more than 15 years of experience in designing and executing nutrition based clinical studies, his participation will be of significant value to the project. He will specifically contribute by designing and manufacturing the intervention products (versus placebo) for WP3 and arrange for the blinding and randomisation process in WP3. He will be the independent guardian of the randomisation code, using appropriate techniques and procedures to ensure maximal blindness of study participants and investigators to the assigned study products. Yet, he will have a system in place to quickly reveal the identity of the study product / group assignment in cases of adverse events. Danone will provide the placebo (lactose, Pharmatose) and the intervention product (Glutival obtained from Cargill). Danone has outsourced the production of the sachets with the gluten intervention / placebo products to NIZO Food Research, Ede, the Netherlands. NIZO will prepare and package the gluten intervention product as well as the placebo according to quality criteria adequate for infants aged 4-6 months.. Every intervention sachet will be filled 1.8 gr Pharmatose and 0.2 gr Glutival (gluten intervention product); the placebo sachets will be filled with 2 gr of Pharmatose.
NIZO will pay special attention to the microbiological assessment of the products and will make sure that the results will be in accordance with the standards of Danone. Also it will be analytically verified whether the blending of the materials has been adequate and resulted into a homogeneous mixture.