NCT02262091

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

October 8, 2013

Last Update Submit

April 9, 2015

Conditions

Elderly People

Outcome Measures

Primary Outcomes (1)

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

    Up to 1 month

Secondary Outcomes (4)

  • 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

Study Arms (2)

Placebo group

PLACEBO COMPARATOR
Dietary Supplement: MaltodextrinBiological: Influenza vaccine (incl. criterion)

Food fibers

EXPERIMENTAL
Dietary Supplement: Food fibersBiological: Influenza vaccine (incl. criterion)

Interventions

Food fibersDIETARY_SUPPLEMENT
Food fibers
MaltodextrinDIETARY_SUPPLEMENT
Placebo group
Influenza vaccine (incl. criterion)BIOLOGICAL
Food fibersPlacebo group

Eligibility Criteria

Age70 Years+
Sexall
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiter des Geriatrischen Zentrums Oldenburg (GZO)

Oldenburg, 26133, Germany

Location

Related Publications (1)

  • 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.

    PMID: 28694834DERIVED

MeSH Terms

Interventions

maltodextrinInfluenza Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 10, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 10, 2015

Record last verified: 2014-09

Locations

DE(1)