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

Sponsored by:	Danone Research
Information provided by:	Danone Research
ClinicalTrials.gov Identifier:	NCT00753961

Purpose

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.

Condition	Intervention
Healthy	Other: fermented dairy product Other: non fermented dairy product

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS

Further study details as provided by Danone Research:

Primary Outcome Measures:

Occurrence of common infectious diseases during the 16 weeks of study product consumption [ Time Frame: 0-16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean duration of common infectious diseases during the 16 weeks of study product consumption. [ Time Frame: 0-16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1340
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator fermented dairy product	Other: fermented dairy product fermented dairy product (2 bottles/day during 16 weeks)
2: Placebo Comparator non fermented acidified dairy product.	Other: non fermented dairy product non fermented dairy product (2 bottles/day during 16 weeks)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753961

Contacts

Contact: Gausseres Nicolas

Nicolas.Gausseres@danone.com

Locations

Belgium
SGS
Antwerpen, Belgium
France
Therapharm
Caen, France
United Kingdom
VEEDA
Plymouth, United Kingdom

Sponsors and Collaborators

Danone Research

More Information

Responsible Party:	DANONE Research ( GAUSSERES Nicolas )
Study ID Numbers:	NU289
Study First Received:	September 16, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00753961
Health Authority:	Cornwall and Plymouth Research Ethics Committee : UK; Commissie voor Medische Ethiek - ZNA Middelheim, Linderdreef 1, 2020 Antwerpen : BELGIUM; Comité Pour la Protection des Personnes de Caen : FRANCE

Keywords provided by Danone Research:

Shiftworkers
volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009