Upper Respiratory InfectionsPhase 2Fib-CC-2014NCT02451163
DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly
A Phase 2 study testing wheat polysaccharides and maltodextrin in people with Upper Respiratory Infections and Common Cold, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Infections, Common Cold
- What is being tested?
- wheat polysaccharides and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center (CRC) Kiel GmbH
Kiel, Schleswig-Holstein, 24118
About this study
Official title: 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.
Read the 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).
- Conditions
- Upper Respiratory Infections, Common Cold
- Being tested
- wheat polysaccharides, maltodextrin
- Medical subject headings
- Respiratory Tract Infections, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheat polysaccharidesDietary supplement
Consumed once daily for 12 weeks.
maltodextrinDietary supplement
Consumed once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| polysaccharides from wheat | Active comparator | 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). Receives: Dietary Supplement: wheat polysaccharides |
| control product | Placebo comparator | 12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each). Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Cumulative severity of common cold episodes
Cumulative severity of common cold episodes (= sum of daily symptom scores acc. to Jackson et al. 1958).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center Kiel GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- BioActor, European Commission
- Responsible party
- Sponsor
- Investigators
- Christiane Laue, MD, Principal investigator, Clinical Research Center Kiel GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451163
- Sponsor's protocol ID
- Fib-CC-2014
- Acronym
- Fib-CC-2014
- Status last verified
- Apr 2016
- First submitted
- 19 May 2015
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Study on the Effect of Polysaccharides From Wheat on Common Cold Infections in Elderly
- ClinicalTrials.gov ID
- NCT02451163
- Acronym / sponsor ID
- Fib-CC-2014 / Fib-CC-2014
- Conditions
- Upper Respiratory Infections, Common Cold
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Clinical Research Center Kiel GmbHUniversity, hospital or other
- Collaborators
- BioActor, European Commission
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polysaccharides from wheat | Active comparator | Dietary Supplement: wheat polysaccharides12.0 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 | Placebo comparator | Dietary Supplement: maltodextrin12.0 g maltodextrin stirred in milk or filtered apple juice (200 ml each). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wheat polysaccharidesConsumed once daily for 12 weeks. | Dietary supplement | polysaccharides from wheat |
| maltodextrinConsumed once daily for 12 weeks. | Dietary supplement | control product |
Primary outcome
Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis
Time frame: 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.
1 secondary outcome
Cumulative severity of common cold episodes
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Laue, MD principal investigator
Clinical Research Center Kiel GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing wheat polysaccharides and maltodextrin in people with Upper Respiratory Infections and Common Cold, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of common cold (CC) based on Jackson et al. 1958 and physicians diagnosis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.