MedTrace Logo

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

NCT01896154 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2016-11-17

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

NPS

Comparison of multiple dietary non-digestible polysaccharides

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Food & Biobased Research - Wageningen UR

    collaborator UNKNOWN

  • Teagasc

    collaborator INDUSTRY

  • Nofima

    collaborator OTHER

  • BioActor B.V.

    collaborator INDUSTRY

  • Swedish Oat Fiber AB

    collaborator UNKNOWN

  • Immitec

    collaborator UNKNOWN

  • Institut Pasteur

    collaborator INDUSTRY

  • University of Bologna

    collaborator OTHER

  • Clinical Research Center Kiel GmbH

    lead OTHER

Principal Investigators

  • Christiane Laue, MD · Clinical Research Center Kiel GmbH

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31
Completion
2014-06-30

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896154 on ClinicalTrials.gov