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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01521182
First received: January 26, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy Free-living Elderly
 Other: 1-Fermented Dairy Product (test)
Other: 2-Milk-based non-fermented dairy product (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Further study details as provided by Danone Research:

Study Start Date: September 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 = Tested product Other: 1-Fermented Dairy Product (test)
1 = Intervention 1 (test product)
Placebo Comparator: 2 = Control product Other: 2-Milk-based non-fermented dairy product (control)
2 = Intervention 2 (control product)

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521182

Locations
Belgium
Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute - University of Antwerp
Wilrijk - Antwerp, Belgium, B-2610
Sponsors and Collaborators
Danone Research
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01521182     History of Changes
Other Study ID Numbers: NU356
Study First Received: January 26, 2012
Last Updated: October 1, 2012
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission

Keywords provided by Danone Research:
Probiotic - dairy product - influenza vaccination - healthy elderly

ClinicalTrials.gov processed this record on May 16, 2013