Common Cold Clinical Trial
— Fib-CC-2014Official title:
A Randomized, Controlled Clinical Study on the Effect of Polysaccharides From Wheat on Common Cold Infections in Elderly
Verified date | April 2016 |
Source | Clinical Research Center Kiel GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 247 |
Est. completion date | March 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Clinical Research Center (CRC) Kiel GmbH | Kiel | Schleswig-Holstein |
Lead Sponsor | Collaborator |
---|---|
Clinical Research Center Kiel GmbH | BioActor, European Commission |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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