HealthyNCT00753961
Effect Of The Consumption Of Fermented Dairy Drink On Common Infections In Shift-Workers
A study testing fermented dairy product and non fermented dairy product in people with Healthy, run by Danone Global Research & Innovation Center at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fermented dairy product and non fermented dairy product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,340 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/female subjects aged 18 to 65 years (bounds included)
- Healthy subjects.
- Subjects working in two- or three-shift work including night work
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS
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.
- Conditions
- Healthy
- Being tested
- fermented dairy product, non fermented dairy product
- Keywords
- Shiftworkers, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fermented dairy productOther
fermented dairy product (2 bottles/day during 16 weeks)
non fermented dairy productOther
non fermented dairy product (2 bottles/day during 16 weeks)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | fermented dairy product Receives: Other: fermented dairy product |
| 2 | Placebo comparator | non fermented acidified dairy product. Receives: Other: non fermented dairy product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of common infectious diseases during the 16 weeks of study product consumption
Measured: 0-16 weeks
Secondary outcomes (1)
Mean duration of common infectious diseases during the 16 weeks of study product consumption.
Measured: 0-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753961
- Sponsor's protocol ID
- NU289
- Status last verified
- Jan 2017
- First submitted
- 16 Sep 2008
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF THE CONSUMPTION OF FERMENTED DAIRY DRINK ON COMMON INFECTIONS IN SHIFT-WORKERS
- ClinicalTrials.gov ID
- NCT00753961
- Acronym / sponsor ID
- NU289
- Conditions
- Healthy
- Keywords
- Shiftworkers, volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: fermented dairy productfermented dairy product |
| 2 | Placebo comparator | Other: non fermented dairy productnon fermented acidified dairy product. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male/female subjects aged 18 to 65 years (bounds included)
- Healthy subjects.
- Subjects working in two- or three-shift work including night work
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fermented dairy productfermented dairy product (2 bottles/day during 16 weeks) | Other | 1 |
| non fermented dairy productnon fermented dairy product (2 bottles/day during 16 weeks) | Other | 2 |
Primary outcome
Occurrence of common infectious diseases during the 16 weeks of study product consumption
Time frame: 0-16 weeks
1 secondary outcome
Mean duration of common infectious diseases during the 16 weeks of study product consumption.
Time frame: 0-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fermented dairy product and non fermented dairy product in people with Healthy, run by Danone Global Research & Innovation Center at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of common infectious diseases during the 16 weeks of study product consumption (time frame: 0-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.