Elderly People
Conditions
Brief summary
The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.
Interventions
DIETARY_SUPPLEMENTFood fibers
DIETARY_SUPPLEMENTMaltodextrin
BIOLOGICALInfluenza vaccine (incl. criterion)
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Inclusion criteria
* Male and female elderly volunteers equal or above age of 70 * Pre-frail and frail subjects (based on Fried's criteria) * Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination * Having obtained his/her (or his/her legal representative's) informed consent
Exclusion criteria
* Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases) * Allergy to eggs or influenza vaccine components. * Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine. * Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment. * Subject who has taken antibiotics in the last 2 months prior to entering the study. * Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts, and/or other dietary supplements. * Personal or family history of Guillain-Barre syndrome * BMI\>35 kg/m2 * Subject who has received blood transfusion or had a blood donation during the last 4 weeks prior to the beginning of this study. * Subject who cannot be expected to comply with the study procedures * Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at 4 weeks post-vaccination in antibody titers levels | Up to 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Measure of seroconversion | Up to 2 months |
| Measure of cytokines production | Up to 2 months 2014 |
| Measure the occurence of clinical endpoints | Up to 2 months |
| Measure of seroprotection | Up to 2 months |
Countries
Germany
Outcome results
None listed