Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521182
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Danone Research

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Free-living Elderly Other: 1-Fermented Dairy Product (test) Other: 2-Milk-based non-fermented dairy product (control) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521182


Locations
Layout table for location information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01521182    
Other Study ID Numbers: NU356
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Keywords provided by Danone Research:
Probiotic - dairy product - influenza vaccination - healthy elderly