Healthy Free-living ElderlyNCT01521182
Effect of the Consumption of a Fermented Dairy Drink on the Immune Function
A study testing 1-Fermented Dairy Product (test) in people with Healthy Free-living Elderly, run by Danone Global Research & Innovation Center at 1 site in Belgium.
Trial summary
The purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Free-living Elderly
- What is being tested?
- 1-Fermented Dairy Product (test)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2011to Jun 2012
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy free-living both gender elderly aged from 65 to 80 years old on the day of inclusion
- Able to comply with all the trial procedures
- Having given written consent to take part in the study prior to participation.
- Body mass index (BMI): 18,5 < BMI < 30 kg/m².
Who cannot join
- Contra-indication to any of the products and procedures used for the study purpose
- Participation in another clinical trial
- People currently institutionalised
- Immunocompromised conditions or other conditions that may impact the immune response or the product effect
- Subjects suffering from a not stabilized chronic disease
- Subjects suffering from a sever acute or chronic disease
Show all 9Show fewer
- Subjects suffering from a condition which is at a stage where it might prevent him/her from being able or willing to comply with the study procedures or completion
- Subject known to be deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Subject identified as employees of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the centre's employees or the Investigator.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute - University of Antwerp
Wilrijk - Antwerp, B-2610
About this study
The purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product.
- Conditions
- Healthy Free-living Elderly
- Being tested
- 1-Fermented Dairy Product (test), 2-Milk-based non-fermented dairy product (control)
- Keywords
- Probiotic - dairy product - influenza vaccination - healthy elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Fermented Dairy Product (test)Other
1 = Intervention 1 (test product)
2-Milk-based non-fermented dairy product (control)Other
2 = Intervention 2 (control product)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Active comparator | Not described Receives: Other: 1-Fermented Dairy Product (test) |
| 2 = Control product | Placebo comparator | Not described Receives: Other: 2-Milk-based non-fermented dairy product (control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Free-living ElderlyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 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
- NCT01521182
- Sponsor's protocol ID
- NU356
- Status last verified
- Sep 2016
- First submitted
- 26 Jan 2012
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of a Fermented Dairy Drink on the Immune Function
- ClinicalTrials.gov ID
- NCT01521182
- Acronym / sponsor ID
- NU356
- Conditions
- Healthy Free-living Elderly
- Keywords
- Probiotic - dairy product - influenza vaccination - healthy elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Jan 2012 (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.
The purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product | Active comparator | Other: 1-Fermented Dairy Product (test) |
| 2 = Control product | Placebo comparator | Other: 2-Milk-based non-fermented dairy product (control) |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Healthy free-living both gender elderly aged from 65 to 80 years old on the day of inclusion
- Able to comply with all the trial procedures
- Having given written consent to take part in the study prior to participation.
- Body mass index (BMI): 18,5 < BMI < 30 kg/m².
Key exclusion criteria (9 listed)
- Contra-indication to any of the products and procedures used for the study purpose
- Participation in another clinical trial
- People currently institutionalised
- Immunocompromised conditions or other conditions that may impact the immune response or the product effect
- Subjects suffering from a not stabilized chronic disease
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 |
|---|---|---|
| 1-Fermented Dairy Product (test)1 = Intervention 1 (test product) | Other | 1 = Tested product |
| 2-Milk-based non-fermented dairy product (control)2 = Intervention 2 (control product) | Other | 2 = Control product |
Primary outcome
Not reported in the source record.
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 20 Sep 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Fermented Dairy Product (test) in people with Healthy Free-living Elderly, run by Danone Global Research & Innovation Center at 1 site in Belgium.
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 4 inclusion and 9 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
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 20 Sep 2016.