Clinical trial NCT02451163: DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly
Official title: A Randomized, Controlled Clinical Study on the Effect of Polysaccharides From Wheat on Common Cold Infections in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Respiratory Infections
Common Cold
Lead sponsor: Clinical Research Center Kiel GmbH
Sponsor class: OTHER
Collaborators: name: BioActor
name: European Commission
First posted: 2015-05-21
Enrollment: 247
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis
timeFrame: 12 weeks
Secondary outcomes:
measure: Cumulative severity of common cold episodes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Clinical Research Center (CRC) Kiel GmbH
state: Schleswig-Holstein
Study officials:
affiliation: Clinical Research Center Kiel GmbH
name: Christiane Laue, MD
role: PRINCIPAL_INVESTIGATOR
References: