DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly (Fib-CC-2014)

Clinical Research Center Kiel

Status and phase: Completed; Phase 2

Conditions: Upper Respiratory Infections; Common Cold

Treatments: Dietary Supplement: maltodextrin; Dietary Supplement: wheat polysaccharides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02451163

Fib-CC-2014

Details and patient eligibility

About

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.

Full 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).

Enrollment: 247 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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247 participants in 2 patient groups, including a placebo group

polysaccharides from wheat

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: wheat polysaccharides

control product

Placebo Comparator group

Description:

12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each).

Treatment:

Dietary Supplement: maltodextrin