Immune Benefits of WGP in Elderly

April 9, 2015 updated by: Nestlé

Strengthening Immunity of Prefrail and Frail Elderly by WGP

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Oldenburg, Germany, 26133
        • Leiter des Geriatrischen Zentrums Oldenburg (GZO)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Dietary supplement: Maltodextrin
Biological: Influenza vaccine (incl. criterion)
Experimental: Food fibers
Biological: Influenza vaccine (incl. criterion)
Dietary supplement: Food fibers

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure of seroconversion
Time Frame: Up to 2 months
Up to 2 months
Measure of cytokines production
Time Frame: Up to 2 months 2014
Up to 2 months 2014
Measure the occurence of clinical endpoints
Time Frame: Up to 2 months
Up to 2 months
Measure of seroprotection
Time Frame: Up to 2 months
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 12.22.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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