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

Study Overview
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Brief Summary
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The aim of the study is to measure the effect of wheat polysaccharides on the occurence of common cold (CC) in elderly during a 12-week consumption period.

Detailed Description
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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).

Official Title
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A Randomized, Controlled Clinical Study on the Effect of Polysaccharides From Wheat on Common Cold Infections in Elderly

Conditions
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Upper Respiratory Infections, Common Cold

Intervention / Treatment
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* Dietary Supplement: wheat polysaccharides
* Dietary Supplement: maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polysaccharides from wheat<br>12.0 g powder containing 10.0 g active ingredient (wheat polysaccharides) as well as 2.0 g filling substance (maltodextrin) stirred in milk or filtered apple juice (200 ml each). | Dietary Supplement: wheat polysaccharides<br>* Consumed once daily for 12 weeks.<br>|
| Placebo Comparator: control product<br>12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each). | Dietary Supplement: maltodextrin<br>* Consumed once daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis | Occurrence of common cold (= number of subjects affected by at least one common cold episode during intervention) according to self-reporting (questionnaire based on Jackson et al. 1958) and physicians diagnosis. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative severity of common cold episodes | Cumulative severity of common cold episodes (= sum of daily symptom scores acc. to Jackson et al. 1958). | 12 weeks |