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

NCT01896154 | Completed Phase 1

• 1 other identifier: Fib-P-2012
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunosenescence

Keywords

dietary fibers, influenza vaccination, HI titres

Outcome Measures

Primary Outcomes (1)

• Geometric mean titre of antibodies against one of the 3 influenza strains in HI test

  3 weeks after vaccination

Study Arms (6)

NPS from yeast

EXPERIMENTAL

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

NPS from shiitake

EXPERIMENTAL

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

NPS from oat

EXPERIMENTAL

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

NPS from wheat

EXPERIMENTAL

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

NPS from Lactobacillus mucosae

EXPERIMENTAL

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

Maltodextrin

PLACEBO COMPARATOR

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

Interventions

NPS DIETARY_SUPPLEMENT

Comparison of multiple dietary non-digestible polysaccharides

Maltodextrin; NPS from Lactobacillus mucosae; NPS from oat; NPS from shiitake; NPS from wheat; NPS from yeast

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Christiane Laue, MD

  Clinical Research Center Kiel GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 11, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 17, 2016

Record last verified: 2015-02