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

Phase 2

Completed

• Conditions: Upper Respiratory Infections; Common Cold
• Interventions: Dietary Supplement: wheat polysaccharides; Dietary Supplement: maltodextrin

• Registration Number: NCT02451163
• Lead Sponsor: Clinical Research Center Kiel GmbH

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).

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-21
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
polysaccharides from wheat	wheat polysaccharides	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).
control product	maltodextrin	12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each).

Primary Outcome Measures

Name	Time	Method
Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative severity of common cold episodes	12 weeks	Cumulative severity of common cold episodes (= sum of daily symptom scores acc. to Jackson et al. 1958).

Trial Locations

Locations (1)

Clinical Research Center (CRC) Kiel GmbH; 🇩🇪 Kiel, Schleswig-Holstein, Germany