Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity (Fib-P-2012)

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

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.

Study Overview

• Status: Completed
• Conditions: Immunosenescence
• Intervention / Treatment: Dietary supplement: NPS

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).

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Dietary supplement: NPS; Comparison of multiple dietary non-digestible polysaccharides
EXPERIMENTAL: 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.	Dietary supplement: NPS; Comparison of multiple dietary non-digestible polysaccharides
EXPERIMENTAL: 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.	Dietary supplement: NPS; Comparison of multiple dietary non-digestible polysaccharides
EXPERIMENTAL: 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.	Dietary supplement: NPS; Comparison of multiple dietary non-digestible polysaccharides
EXPERIMENTAL: 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.	Dietary supplement: NPS; Comparison of multiple dietary non-digestible polysaccharides
PLACEBO_COMPARATOR: 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.	Dietary supplement: NPS; Comparison of multiple dietary non-digestible polysaccharides

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinical Research Center Kiel GmbH
• Collaborators: University of Bologna; Institut Pasteur; European Commission; Nofima; Teagasc; BioActor B.V.; Food & Biobased Research - Wageningen UR; Swedish Oat Fiber AB; Immitec

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 8, 2013
• First Posted (ESTIMATE): July 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: dietary fibers, influenza vaccination, HI titres
• Other Study ID Numbers: Fib-P-2012