NCT00753961

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,340

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable healthy

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

September 16, 2008

Last Update Submit

January 25, 2017

Conditions

Healthy

Keywords

Shiftworkersvolunteers

Outcome Measures

Primary Outcomes (1)

  • Occurrence of common infectious diseases during the 16 weeks of study product consumption

    0-16 weeks

Secondary Outcomes (1)

  • Mean duration of common infectious diseases during the 16 weeks of study product consumption.

    0-16 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

fermented dairy product

Other: fermented dairy product

2

PLACEBO COMPARATOR

non fermented acidified dairy product.

Other: non fermented dairy product

Interventions

fermented dairy productOTHER

fermented dairy product (2 bottles/day during 16 weeks)

1
non fermented dairy productOTHER

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

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/female subjects aged 18 to 65 years (bounds included)
  • Healthy subjects.
  • Subjects working in two- or three-shift work including night work

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

SGS

Antwerp, Belgium

Location

Therapharm

Caen, France

Location

Hospital de la Santa Creu

Barcelona, Spain

Location

VEEDA

Plymouth, United Kingdom

Location

MeSH Terms

Interventions

Cultured Milk Products

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 17, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2010

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

BE(1)FR(1)GB(1)ES(1)