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OpenTrials
Completed

NCT Number: NCT02262091

Immune Benefits of WGP in Elderly

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

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiter des Geriatrischen Zentrums Oldenburg (GZO)

Oldenburg, 26133, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food fibers

Dietary Supplement

Maltodextrin

Dietary Supplement

Influenza vaccine (incl. criterion)

Biological

Primary outcomes

  1. Change from baseline at 4 weeks post-vaccination in antibody titers levels

    Time frame: Up to 1 month

Secondary outcomes

  1. Measure of seroconversion

    Time frame: Up to 2 months

  2. Measure of cytokines production

    Time frame: Up to 2 months 2014

  3. Measure the occurence of clinical endpoints

    Time frame: Up to 2 months

  4. Measure of seroprotection

    Time frame: Up to 2 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Strengthening Immunity of Prefrail and Frail Elderly by WGP

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2014
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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