NCT01896154

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Clinical Research Center Kiel GmbH · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Immunosenescence

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NPS	Comparison of multiple dietary non-digestible polysaccharides

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2014-06-01
• First posted: 2013-07-11
• Last updated: 2016-11-17