Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized, Controlled Clinical Study on the Effect of Non-digestible Polysaccharides (NPS) on the Immune Response to Influenza Vaccination in Elderly

Conditions
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Immunosenescence

Intervention / Treatment
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* Dietary Supplement: NPS


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPS from yeast<br>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. | Dietary Supplement: NPS<br>* Comparison of multiple dietary non-digestible polysaccharides<br>|
| Experimental: NPS from shiitake<br>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. | Dietary Supplement: NPS<br>* Comparison of multiple dietary non-digestible polysaccharides<br>|
| Experimental: NPS from oat<br>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. | Dietary Supplement: NPS<br>* Comparison of multiple dietary non-digestible polysaccharides<br>|
| Experimental: NPS from wheat<br>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. | Dietary Supplement: NPS<br>* Comparison of multiple dietary non-digestible polysaccharides<br>|
| Experimental: NPS from Lactobacillus mucosae<br>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. | Dietary Supplement: NPS<br>* Comparison of multiple dietary non-digestible polysaccharides<br>|
| Placebo Comparator: Maltodextrin<br>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. | Dietary Supplement: NPS<br>* Comparison of multiple dietary non-digestible polysaccharides<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titre of antibodies against one of the 3 influenza strains in HI test |  | 3 weeks after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fibers, influenza vaccination, HI titres