A Randomized, Controlled Clinical Study on the Effect of Non-digestible Polysaccharides (NPS) on the Immune Response to Influenza Vaccination in Elderly
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Immunosenescence
- Sponsor
- Clinical Research Center Kiel GmbH
- Enrollment
- 239
- Primary Endpoint
- Geometric mean titre of antibodies against one of the 3 influenza strains in HI test
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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)
Outcomes
Primary Outcomes
Geometric mean titre of antibodies against one of the 3 influenza strains in HI test
Time Frame: 3 weeks after vaccination