Healthy Free-living Elderly Clinical Trial
| Verified date | September 2016 |
| Source | Danone Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics CommitteeGermany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 550 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 65 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute - University of Antwerp | Wilrijk - Antwerp |
| Lead Sponsor | Collaborator |
|---|---|
| Danone Research |
Belgium,