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

• 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