Effect Of The Consumption Of Fermented Dairy Drink On Com... | NCT00753961

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

NCT00753961

Sponsor

Danone Global Research & Innovation Center

Status

Completed

Last Update Posted

Jan 27, 2017Estimated

Enrollment

1,340Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

fermented dairy product
non fermented dairy product

Countries

Belgium
France
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 16, 2008

First Submission Date that Met QC Criteria

Sep 16, 2008

First Posted Date

Sep 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2017

Last Update Posted Date

Jan 27, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	fermented dairy product	Other: fermented dairy product
2	Placebo Comparator	non fermented acidified dairy product.	Other: non fermented dairy product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fermented dairy product	Other	fermented dairy product (2 bottles/day during 16 weeks)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of common infectious diseases during the 16 weeks of study product consumption		0-16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean duration of common infectious diseases during the 16 weeks of study product consumption.		0-16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D043302	Cultured Milk Products

Ancestor Terms

ID	Term
D008892	Milk
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
SGS		Antwerp			Belgium
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