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

Common Cold Clinical Trial

— Fib-CC-2014  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451163
• Other study ID #: Fib-CC-2014
• Status: Completed
• Phase: Phase 2
• First received: May 19, 2015
• Last updated: April 11, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• 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

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold
• Infection
• Respiratory Tract Infections
• Upper Respiratory Infections

Intervention

Dietary Supplement:
• wheat polysaccharides
Consumed once daily for 12 weeks.
• maltodextrin
Consumed once daily for 12 weeks.

Locations

Country	Name	City	State
Germany	Clinical Research Center (CRC) Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Research Center Kiel GmbH	BioActor, European Commission

Country where clinical trial is conducted

Germany, 

Outcome

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