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

Primary Purpose

Upper Respiratory Infections, Common Cold

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
wheat polysaccharides
maltodextrin
Sponsored by
Clinical Research Center Kiel GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Infections

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Clinical Research Center (CRC) Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

polysaccharides from wheat

control product

Arm 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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 19, 2015
Last Updated
April 11, 2016
Sponsor
Clinical Research Center Kiel GmbH
Collaborators
BioActor, European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02451163
Brief Title
DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly
Acronym
Fib-CC-2014
Official Title
A Randomized, Controlled Clinical Study on the Effect of Polysaccharides From Wheat on Common Cold Infections in Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Center Kiel GmbH
Collaborators
BioActor, European Commission

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Infections, Common Cold

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polysaccharides from wheat
Arm Type
Active Comparator
Arm 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).
Arm Title
control product
Arm Type
Placebo Comparator
Arm Description
12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each).
Intervention Type
Dietary Supplement
Intervention Name(s)
wheat polysaccharides
Intervention Description
Consumed once daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
Consumed once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cumulative severity of common cold episodes
Description
Cumulative severity of common cold episodes (= sum of daily symptom scores acc. to Jackson et al. 1958).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Laue, MD
Organizational Affiliation
Clinical Research Center Kiel GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center (CRC) Kiel GmbH
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24118
Country
Germany

12. IPD Sharing Statement

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

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