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

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Danone

Status

Completed

Conditions

Healthy Free-living Elderly

Treatments

Other: 2-Milk-based non-fermented dairy product (control)
Other: 1-Fermented Dairy Product (test)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

550 patients

Sex

All

Ages

65 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

550 participants in 2 patient groups, including a placebo group

1 = Tested product
Active Comparator group
Treatment:
Other: 1-Fermented Dairy Product (test)
2 = Control product
Placebo Comparator group
Treatment:
Other: 2-Milk-based non-fermented dairy product (control)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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