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

NCT ID: NCT01521182

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

1 = Tested product

Group Type: ACTIVE_COMPARATOR

1-Fermented Dairy Product (test)

Intervention Type: OTHER

1 = Intervention 1 (test product)

2 = Control product

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: OTHER

2 = Intervention 2 (control product)

Interventions

1-Fermented Dairy Product (test)

1 = Intervention 1 (test product)

Intervention Type: OTHER

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

2 = Intervention 2 (control product)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Wilrijk - Antwerp, , Belgium

Countries

Belgium

Other Identifiers

NU356

Identifier Type: -

Identifier Source: org_study_id