Immune Benefits of WGP in Elderly

NCT ID: NCT02262091

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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Conditions

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Elderly People

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo group

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Influenza vaccine (incl. criterion)

Intervention Type BIOLOGICAL

Food fibers

Group Type EXPERIMENTAL

Food fibers

Intervention Type DIETARY_SUPPLEMENT

Influenza vaccine (incl. criterion)

Intervention Type BIOLOGICAL

Interventions

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Food fibers

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Influenza vaccine (incl. criterion)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leiter des Geriatrischen Zentrums Oldenburg (GZO)

Oldenburg, , Germany

Site Status

Countries

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Germany

References

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Bauer JM, De Castro A, Bosco N, Romagny C, Diekmann R, Benyacoub J, Vidal K. Influenza vaccine response in community-dwelling German prefrail and frail individuals. Immun Ageing. 2017 Jul 6;14:17. doi: 10.1186/s12979-017-0098-z. eCollection 2017.

Reference Type DERIVED
PMID: 28694834 (View on PubMed)

Other Identifiers

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12.22.NRC

Identifier Type: -

Identifier Source: org_study_id

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