Effect of the Consumption of a Fermented Dairy Drink on the Immune Function

Not Applicable

Completed

• Conditions: Healthy Free-living Elderly
• Interventions: Other: 1-Fermented Dairy Product (test); Other: 2-Milk-based non-fermented dairy product (control)

• Registration Number: NCT01521182
• Lead Sponsor: Danone Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-30
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 = Tested product	1-Fermented Dairy Product (test)	-
2 = Control product	2-Milk-based non-fermented dairy product (control)	-

Trial Locations

Locations (1)

Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute - University of Antwerp; 🇧🇪 Wilrijk - Antwerp, Belgium