ImmunosenescencePhase 1/2Fib-P-2012NCT01896154
Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity
A Phase 1/2 study testing NPS in people with Immunosenescence, run by Clinical Research Center Kiel GmbH.
Trial summary
The aim of the study is to estimate the effect size of a 5-week consumption period of different dietary non-digestible polysaccharides (NPS) on antibody response to influenza vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether these NPS may enable enhancement of immune defence… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence
- What is being tested?
- NPS
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jun 2014
- Phase
- Phase 1/2
- 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
- Free-living postmenopausal woman and men aged ≥ 50 years willing to have influenza vaccination season 2012/2013
- 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 willing to sustain on a low dietary fibre diet for 7 weeks.
- written informed consent
Who cannot join
- Subjects enrolled in another clinical study in the last 4 weeks
- Subjects already vaccinated against influenza during 2012-2013 with either the influenza vaccine used in the present study or another influenza vaccine
- vaccination against influenza within the previous 10 months
- suffering from influenza or influenza-like illness within the previous 10 months
- other vaccinations during and within 2 months before the study
- symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract in the last 4 weeks before inclusion
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- known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
- active autoimmune diseases
- allergy or hypersensitivity to any component of the vaccine (e. g. chicken egg protein, certain antibiotics)(s. a. 9.2)
- allergy or hypersensitivity to any component of the test product (e. g. yeast, gluten, shiitake mushrooms)
- allergy to latex
- known coeliac disease (gluten enteropathy)
- 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
- severe chronic disease (cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, renal, hepatic or cardiac diseases, COPD, respiratory insufficiency)
- chronic abdominal pain
- malformation of fingers
- systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: 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
- other treatments likely to interfere with study outcome (e.g. laxatives, body weight management and/or medication)
- treatments with calcium antagonists and nitrates and alpha blockers
- diabetes mellitus on drug therapy
- severe neurological, cognitive or psychiatric diseases
- surgery or intervention requiring general anaesthesia within 2 months before the study
- vegetarian, vegan
- eating disorders (e.g. anorexia, bulimia)
- alcohol and drug abuse
- pregnancy or lactation
- legal incapacity
- blood parameters: Hb < 12 g/dL Liver transaminases (ALT, AST) > 2-fold increased Serum creatinine > 1,2 mg/dL
About this study
Official title: A Randomized, Controlled Clinical Study on the Effect of Non-digestible Polysaccharides (NPS) on the Immune Response to Influenza Vaccination in Elderly
The aim of the study is to estimate the effect size of a 5-week consumption period of different dietary non-digestible polysaccharides (NPS) on antibody response to influenza vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether these NPS may enable enhancement of immune defence and to estimate the sample size for a confirmative trial. Furthermore the effects on faecal microbiota and its metabolites will be investigated.
Read the detailed description
The study is conducted in the frame of the collaborative project 'FibeBiotics' (Nr. 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
- Immunosenescence
- Being tested
- NPS
- Keywords
- dietary fibers, influenza vaccination, HI titres
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPSDietary supplement
Comparison of multiple dietary non-digestible polysaccharides
| Study group | Role | What they receive |
|---|---|---|
| NPS from yeast | Experimental | Powder containing the active ingredients (500mg NPS from yeast) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks. 2 weeks before vaccination and 3 weeks after vaccination. Receives: Dietary Supplement: NPS |
| NPS from shiitake | Experimental | Powder containing the active ingredient (500mg NPS from shitake) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. Receives: Dietary Supplement: NPS |
| NPS from oat | Experimental | Powder containing the active ingredient (10g NPS from oat) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. Receives: Dietary Supplement: NPS |
| NPS from wheat | Experimental | Powder containing the active ingredient (10g NPS from wheat) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. Receives: Dietary Supplement: NPS |
| NPS from Lactobacillus mucosae | Experimental | Powder containing the active ingredient (2,3g NPS from L. mucosae) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. Receives: Dietary Supplement: NPS |
| Maltodextrin | Placebo comparator | 12.0 g Maltodextrin and flavour with identical/similar appearance and taste (when mixed in drink), consumed once daily as described for the active products (NPS. Receives: Dietary Supplement: NPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titre of antibodies against one of the 3 influenza strains in HI test
Measured: 3 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosenescenceStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center Kiel GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Food & Biobased Research - Wageningen UR, Teagasc, Nofima, BioActor B.V., Swedish Oat Fiber AB, Immitec, Institut Pasteur, University of Bologna
- Responsible party
- Sponsor
- Investigators
- Christiane Laue, MD, Principal investigator, Clinical Research Center Kiel GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896154
- Sponsor's protocol ID
- Fib-P-2012
- Acronym
- Fib-P-2012
- Status last verified
- Feb 2015
- First submitted
- 2 Jul 2013
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 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 Non-digestible Polysaccharides (NPS) on the Immune Response to Influenza Vaccination in Elderly
- ClinicalTrials.gov ID
- NCT01896154
- Acronym / sponsor ID
- Fib-P-2012 / Fib-P-2012
- Conditions
- Immunosenescence
- Keywords
- dietary fibers, influenza vaccination, HI titres
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Clinical Research Center Kiel GmbHUniversity, hospital or other
- Collaborators
- European Commission, Food & Biobased Research - Wageningen UR, Teagasc, Nofima, BioActor B.V., Swedish Oat Fiber AB, Immitec, Institut Pasteur, University of Bologna
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Jul 2013 (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 estimate the effect size of a 5-week consumption period of different dietary non-digestible polysaccharides (NPS) on antibody response to influenza vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether these NPS may enable enhancement of immune defence and to estimate the sample size for a confirmative trial. Furthermore the effects on faecal microbiota and its metabolites will be investigated.
Detailed description
The study is conducted in the frame of the collaborative project 'FibeBiotics' (Nr. 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NPS from yeast | Experimental | Dietary Supplement: NPSPowder containing the active ingredients (500mg NPS from yeast) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks. 2 weeks before vaccination and 3 weeks after vaccination. |
| NPS from shiitake | Experimental | Dietary Supplement: NPSPowder containing the active ingredient (500mg NPS from shitake) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. |
| NPS from oat | Experimental | Dietary Supplement: NPSPowder containing the active ingredient (10g NPS from oat) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. |
| NPS from wheat | Experimental | Dietary Supplement: NPSPowder containing the active ingredient (10g NPS from wheat) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. |
| NPS from Lactobacillus mucosae | Experimental | Dietary Supplement: NPSPowder containing the active ingredient (2,3g NPS from L. mucosae) as well as filling substances (maltodextrins) and flavour adding up to 12.0 g altogether in sachets; consumed once daily after having been stirred in milk or filtered apple juice (ca. 200 ml/ 1 glass) for 5 weeks: 2 weeks before vaccination and 3 weeks after vaccination. |
| Maltodextrin | Placebo comparator | Dietary Supplement: NPS12.0 g Maltodextrin and flavour with identical/similar appearance and taste (when mixed in drink), consumed once daily as described for the active products (NPS. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Free-living postmenopausal woman and men aged ≥ 50 years willing to have influenza vaccination season 2012/2013
- 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 willing to sustain on a low dietary fibre diet for 7 weeks.
- written informed consent
Key exclusion criteria (29 listed)
- Subjects enrolled in another clinical study in the last 4 weeks
- Subjects already vaccinated against influenza during 2012-2013 with either the influenza vaccine used in the present study or another influenza vaccine
- vaccination against influenza within the previous 10 months
- suffering from influenza or influenza-like illness within the previous 10 months
- other vaccinations during and within 2 months before the study
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 |
|---|---|---|
| NPSComparison of multiple dietary non-digestible polysaccharides | Dietary supplement | Maltodextrin, NPS from Lactobacillus mucosae, NPS from oat, NPS from shiitake, NPS from wheat, NPS from yeast |
Primary outcome
Geometric mean titre of antibodies against one of the 3 influenza strains in HI test
Time frame: 3 weeks after vaccination
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 17 Nov 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
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NPS in people with Immunosenescence, run by Clinical Research Center Kiel GmbH.
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 29 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Geometric mean titre of antibodies against one of the 3 influenza strains in HI test (time frame: 3 weeks after vaccination). 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 17 Nov 2016.