Immune Benefits of WGP in Elderly

Not Applicable

Completed

• Conditions: Elderly People
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Food fibers; Biological: Influenza vaccine (incl. criterion)

• Registration Number: NCT02262091
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study Start: 2014-08
• Status Verified: 2014-09
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food fibers	Influenza vaccine (incl. criterion)	-
Placebo group	Maltodextrin	-
Placebo group	Influenza vaccine (incl. criterion)	-
Food fibers	Food fibers	-

Primary Outcome Measures

Name	Time	Method
Change from baseline at 4 weeks post-vaccination in antibody titers levels	Up to 1 month

Secondary Outcome Measures

Name	Time	Method
Measure of seroprotection	Up to 2 months
Measure the occurence of clinical endpoints	Up to 2 months
Measure of seroconversion	Up to 2 months
Measure of cytokines production	Up to 2 months 2014

Trial Locations

Locations (1)

Leiter des Geriatrischen Zentrums Oldenburg (GZO); 🇩🇪 Oldenburg, Germany