DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly

The study is conducted in the frame of the collaborative project 'FibeBiotics' (No. 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

• men and postmenopausal women aged ≥ 50
• 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 willingness to sustain a low dietary fibre diet for 14 weeks
• written informed consent

Exclusion criteria

• subjects currently enrolled in another clinical study
• subjects having finished another clinical study within the last 4 weeks before inclusion
• surgery or intervention requiring general anaesthesia within 2 months before the study
• current symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract
• history of allergic rhinitis, allergic asthma, anaphylactic shock, quincke edema, food allergy (type I allergy)
• allergy or hypersensitivity to any component of the test product (e. g. wheat, corn)
• known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
• active autoimmune diseases
• severe chronic disease (COPD, respiratory insufficiency, cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, severe renal, hepatic or cardiac diseases)
• known coeliac disease (gluten enteropathy)
• chronic systemic or chronic topical treatment likely to interfere with evaluation of the study parameters: antiallergic drugs, 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 (in the last 4 weeks before inclusion)
• diabetes mellitus
• other chronic treatments likely to interfere with study outcome: e.g. laxatives, body weight management and/or medication
• chronic abdominal pain
• 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
• vegetarian, vegan diet
• eating disorders (e.g. anorexia, bulimia)
• alcohol and drug abuse
• severe neurological, cognitive or psychiatric diseases
• subjects not understanding or speaking fluently German
• legal incapacity