Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity
NCT ID: NCT01896154
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
239 participants
INTERVENTIONAL
2012-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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NPS from yeast
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.
NPS
Comparison of multiple dietary non-digestible polysaccharides
NPS from shiitake
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.
NPS
Comparison of multiple dietary non-digestible polysaccharides
NPS from oat
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.
NPS
Comparison of multiple dietary non-digestible polysaccharides
NPS from wheat
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.
NPS
Comparison of multiple dietary non-digestible polysaccharides
NPS from Lactobacillus mucosae
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.
NPS
Comparison of multiple dietary non-digestible polysaccharides
Maltodextrin
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.
NPS
Comparison of multiple dietary non-digestible polysaccharides
Interventions
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NPS
Comparison of multiple dietary non-digestible polysaccharides
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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European Commission
OTHER
Food & Biobased Research - Wageningen UR
UNKNOWN
Teagasc
INDUSTRY
Nofima
OTHER
BioActor B.V.
INDUSTRY
Swedish Oat Fiber AB
UNKNOWN
Immitec
UNKNOWN
Institut Pasteur
INDUSTRY
University of Bologna
OTHER
Clinical Research Center Kiel GmbH
OTHER
Responsible Party
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Principal Investigators
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Christiane Laue, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Center Kiel GmbH
Other Identifiers
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Fib-P-2012
Identifier Type: -
Identifier Source: org_study_id