Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity
Phase 1
Completed
- Conditions
- Immunosenescence
- Interventions
- Dietary Supplement: NPS
- Registration Number
- NCT01896154
- Lead Sponsor
- Clinical Research Center Kiel GmbH
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NPS from yeast NPS 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 from shiitake NPS 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 from oat NPS 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 from wheat NPS 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 from Lactobacillus mucosae NPS 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. Maltodextrin NPS 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.
- Primary Outcome Measures
Name Time Method Geometric mean titre of antibodies against one of the 3 influenza strains in HI test 3 weeks after vaccination
- Secondary Outcome Measures
Name Time Method