Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity

The study is conducted in the frame of the collaborative project 'FibeBiotics' (Nr. 289517) (Fibers as support of the Gut and Immune function of Elderly - From polysaccharide compound to health claim) within the Seventh Framework Programme (FP7) for Research and Technological Development of the European Union (EU).

Inclusion criteria

• Free-living postmenopausal woman and men aged ≥ 50 years willing to have influenza vaccination season 2012/2013
• willingness to abstain as far as possible from food and supplements containing probiotics, prebiotic supplements, other fermented products, supplements containing vitamins and minerals as well as willing to sustain on a low dietary fibre diet for 7 weeks.
• written informed consent

Exclusion criteria

• Subjects enrolled in another clinical study in the last 4 weeks
• Subjects already vaccinated against influenza during 2012-2013 with either the influenza vaccine used in the present study or another influenza vaccine
• vaccination against influenza within the previous 10 months
• suffering from influenza or influenza-like illness within the previous 10 months
• other vaccinations during and within 2 months before the study
• symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract in the last 4 weeks before inclusion
• known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
• active autoimmune diseases
• allergy or hypersensitivity to any component of the vaccine (e. g. chicken egg protein, certain antibiotics)(s. a. 9.2)
• allergy or hypersensitivity to any component of the test product (e. g. yeast, gluten, shiitake mushrooms)
• allergy to latex
• known coeliac disease (gluten enteropathy)
• bowel movement less than 3 times per week
• subjects, who meet 2 or more Rome III criteria for constipation or who take laxatives on a regular basis
• severe chronic disease (cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, renal, hepatic or cardiac diseases, COPD, respiratory insufficiency)
• chronic abdominal pain
• malformation of fingers
• systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases
• other treatments likely to interfere with study outcome (e.g. laxatives, body weight management and/or medication)
• treatments with calcium antagonists and nitrates and alpha blockers
• diabetes mellitus on drug therapy
• severe neurological, cognitive or psychiatric diseases
• surgery or intervention requiring general anaesthesia within 2 months before the study
• vegetarian, vegan
• eating disorders (e.g. anorexia, bulimia)
• alcohol and drug abuse
• pregnancy or lactation
• legal incapacity
• blood parameters: Hb < 12 g/dL Liver transaminases (ALT, AST) > 2-fold increased Serum creatinine > 1,2 mg/dL