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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01521182
Enrollment
550
Registered
2012-01-30
Start date
2011-09-30
Completion date
2012-06-30
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Free-living Elderly

Keywords

Probiotic - dairy product - influenza vaccination - healthy elderly

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.

Interventions

1 = Intervention 1 (test product)

OTHER2-Milk-based non-fermented dairy product (control)

2 = Intervention 2 (control product)

Sponsors

Danone Global Research & Innovation Center
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes

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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026