Clinical trial NCT01896154: Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity
Official title: A Randomized, Controlled Clinical Study on the Effect of Non-digestible Polysaccharides (NPS) on the Immune Response to Influenza Vaccination in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Immunosenescence
Keywords: dietary fibers, influenza vaccination, HI titres
Lead sponsor: Clinical Research Center Kiel GmbH
Sponsor class: OTHER
Collaborators: name: European Commission
name: Food & Biobased Research - Wageningen UR
name: Teagasc
name: Nofima
name: BioActor B.V.
name: Swedish Oat Fiber AB
name: Immitec
name: Institut Pasteur
name: University of Bologna
First posted: 2013-07-11
Enrollment: 239
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

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)
* 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

Primary outcomes:
measure: Geometric mean titre of antibodies against one of the 3 influenza strains in HI test
timeFrame: 3 weeks after vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Center Kiel GmbH
name: Christiane Laue, MD
role: PRINCIPAL_INVESTIGATOR
References: