Effect of the Consumption of a Fermented Dairy Drink on the Immune Function
ClinicalTrials.gov ID
NCT01521182
Lead Sponsor
Danone Global Research & Innovation CenterINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
550Actual
Last Update Posted
Sep 20, 2016Estimated
Start Date
Sep 2011
Primary Completion Date
Jun 2012Actual
Completion Date
Jun 2012Actual
Brief Summary
The purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product.
Healthy free-living both gender elderly aged from 65 to 80 years old on the day of inclusion
Able to comply with all the trial procedures
Having given written consent to take part in the study prior to participation.
Body mass index (BMI): 18,5 < BMI < 30 kg/m².
Exclusion Criteria:
Contra-indication to any of the products and procedures used for the study purpose
Participation in another clinical trial
People currently institutionalised
Immunocompromised conditions or other conditions that may impact the immune response or the product effect
Subjects suffering from a not stabilized chronic disease
Subjects suffering from a sever acute or chronic disease
Subjects suffering from a condition which is at a stage where it might prevent him/her from being able or willing to comply with the study procedures or completion
Subject known to be deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Subject identified as employees of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the centre's employees or the Investigator.
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
No central contacts
There are no central contacts for this study.
Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute - University of Antwerp
Wilrijk - Antwerp, B-2610, Belgium
Lead Sponsor
Danone Global Research & Innovation CenterINDUSTRY