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

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

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.

Study Overview

• Status: Completed
• Conditions: Common Cold; Upper Respiratory Infections
• Intervention / Treatment: Dietary supplement: wheat polysaccharides; Dietary supplement: maltodextrin

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 Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24118
      • Clinical Research Center (CRC) Kiel GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: polysaccharides from wheat; 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).	Dietary supplement: wheat polysaccharides; Consumed once daily for 12 weeks.
Placebo Comparator: control product; 12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each).	Dietary supplement: maltodextrin; Consumed once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clinical Research Center Kiel GmbH
• Collaborators: European Commission; BioActor

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Estimate): April 12, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Picornaviridae Infections; Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: Fib-CC-2014