Immune Benefits of WGP in Elderly

Elderly People Clinical Trial

Official title:

Strengthening Immunity of Prefrail and Frail Elderly by WGP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262091
• Other study ID #: 12.22.NRC
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: April 9, 2015
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Elderly People

Intervention

Dietary Supplement:
• Food fibers

• Maltodextrin

Biological:
• Influenza vaccine (incl. criterion)

Locations

Country	Name	City	State
Germany	Leiter des Geriatrischen Zentrums Oldenburg (GZO)	Oldenburg

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline at 4 weeks post-vaccination in antibody titers levels		Up to 1 month	No
Secondary	Measure of seroconversion		Up to 2 months	No
Secondary	Measure of cytokines production		Up to 2 months 2014	No
Secondary	Measure the occurence of clinical endpoints		Up to 2 months	Yes
Secondary	Measure of seroprotection		Up to 2 months	No