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| Name | Class |
|---|---|
| European Commission | OTHER |
| Food & Biobased Research - Wageningen UR | UNKNOWN |
| Teagasc | INDUSTRY |
| Nofima |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPS | Dietary Supplement | Comparison of multiple dietary non-digestible polysaccharides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titre of antibodies against one of the 3 influenza strains in HI test | 3 weeks after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Laue, MD | Clinical Research Center Kiel GmbH | Principal Investigator |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| OTHER |
| BioActor B.V. | INDUSTRY |
| Swedish Oat Fiber AB | UNKNOWN |
| Immitec | UNKNOWN |
| Institut Pasteur | INDUSTRY |
| University of Bologna | OTHER |
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|
| 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. |
|
| 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. |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |