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NCT00753961 Clinical Trial

Effect Of The Consumption Of Fermented Dairy Drink On Common Infections In Shift-Workers

Healthy Clinical Trial

Official title:
EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00753961
Other study ID # NU289
Secondary ID
Status Completed
Phase N/A
First received September 16, 2008
Last updated January 25, 2017
Start date September 2008
Est. completion date April 2010

Study information
Verified date January 2017
Source Danone Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical study plans to investigate the effect of the consumption of a fermented dairy drink on the occurrence of common infections. This study will be performed in a healthy adult population of shift workers.

Recruitment information / eligibility
Status Completed
Enrollment 1340
Est. completion date April 2010
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Male/female subjects aged 18 to 65 years (bounds included)

- Healthy subjects.

- Subjects working in two- or three-shift work including night work

Exclusion Criteria:

- Subject with any food allergy

- Subject in a situation that, in the investigator opinion, could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• fermented dairy product
fermented dairy product (2 bottles/day during 16 weeks)
• non fermented dairy product
non fermented dairy product (2 bottles/day during 16 weeks)

Locations
Country Name City State
Belgium SGS Antwerpen
France Therapharm Caen
Spain Hospital de la Santa Creu Barcelona
United Kingdom VEEDA Plymouth

Sponsors (1)
Lead Sponsor Collaborator
Danone Research

Countries where clinical trial is conducted

Belgium,  France,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of common infectious diseases during the 16 weeks of study product consumption 0-16 weeks
Secondary Mean duration of common infectious diseases during the 16 weeks of study product consumption. 0-16 weeks
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