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

NCT01521182 | Completed

• 1 other identifier: NU356
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Free-living Elderly

Keywords

Probiotic - dairy product - influenza vaccination - healthy elderly

Study Arms (2)

1 = Tested product

ACTIVE COMPARATOR

Other: 1-Fermented Dairy Product (test)

2 = Control product

PLACEBO COMPARATOR

Other: 2-Milk-based non-fermented dairy product (control)

Interventions

1-Fermented Dairy Product (test) OTHER

1 = Intervention 1 (test product)

1 = Tested product

2-Milk-based non-fermented dairy product (control) OTHER

2 = Intervention 2 (control product)

2 = Control product

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute - University of Antwerp

Wilrijk - Antwerp, B-2610, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 30, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

BE (1)