Immune Benefits of WGP in Elderly

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.

Official Title
-----------------
Strengthening Immunity of Prefrail and Frail Elderly by WGP

Conditions
-----------------
Elderly People

Intervention / Treatment
-----------------
* Dietary Supplement: Food fibers
* Dietary Supplement: Maltodextrin
* Biological: Influenza vaccine (incl. criterion)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br> | Dietary Supplement: Maltodextrin<br> <br> Biological: Influenza vaccine (incl. criterion)<br> <br> |
| Experimental: Food fibers<br> | Dietary Supplement: Food fibers<br> <br> Biological: Influenza vaccine (incl. criterion)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at 4 weeks post-vaccination in antibody titers levels |  | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |