Healthy Adult WomenNCT01398163
A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women
A study testing 1-Fermented Dairy Product (test) in people with Healthy Adult Women, run by Danone Global Research & Innovation Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Women
- What is being tested?
- 1-Fermented Dairy Product (test)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women, right-handed, aged from 18 to 60 years
- Subject of normal body weight or with overweight i.e. not obese (body mass index between 18 and 30 kg/m2).
- For fertile women, complying with one of the other medically approved methods of contraception
Who cannot join
- Subject with any current psychiatric or eating or suicidal attempt disorder, or history of such disorder.
- Subject with any history of chronic GI disorder or disease.
- Subject with any significant active or prior metabolic disorder or disease.
- Subject with any use of probiotic supplements or antibiotics in the previous month.
- Subject with current use of any medications with potential central nervous system effects (antidepressants, anxiolytics, opiate pain medications...).
- Subject with allergy or hypersensitivity to milk proteins or lactose intolerance or immunodeficiency
- Subjects with claustrophobia or other condition (such as metallic implants) that would preclude MRI scanning
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA - University
Los Angeles, California, 90095-7170
About this study
Official title: A f-MRI STUDY OF AFFECTIVE CHANGES ASSOCIATED WITH FOUR WEEKS CONSUMPTION OF A FERMENTED DAIRY PRODUCT IN HEALTHY WOMEN
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being.
- Conditions
- Healthy Adult Women
- Being tested
- 1-Fermented Dairy Product (test), 2-Milk-based non-fermented dairy product(control)
- Keywords
- probiotics, digestive well-being, fMRI, brain-gut axis
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
Arm 1 - Intervention 1 (probiotics)
2-Milk-based non-fermented dairy product(control)Other
Arm 2 - Intervention 2 (control)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Experimental | Not described Receives: Other: 1-Fermented Dairy Product (test) |
| 2 = Control product | Active comparator | Not described Receives: Other: 2-Milk-based non-fermented dairy product(control) |
| 3 = No product | No intervention | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult WomenStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 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
- NCT01398163
- Sponsor's protocol ID
- NU271
- Status last verified
- Nov 2016
- First submitted
- 19 Jul 2011
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A f-MRI STUDY OF AFFECTIVE CHANGES ASSOCIATED WITH FOUR WEEKS CONSUMPTION OF A FERMENTED DAIRY PRODUCT IN HEALTHY WOMEN
- ClinicalTrials.gov ID
- NCT01398163
- Acronym / sponsor ID
- NU271
- Conditions
- Healthy Adult Women
- Keywords
- probiotics, digestive well-being, fMRI, brain-gut axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jul 2011 (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 evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product | Experimental | Other: 1-Fermented Dairy Product (test) |
| 2 = Control product | Active comparator | Other: 2-Milk-based non-fermented dairy product(control) |
| 3 = No product | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women, right-handed, aged from 18 to 60 years
- Subject of normal body weight or with overweight i.e. not obese (body mass index between 18 and 30 kg/m2).
- For fertile women, complying with one of the other medically approved methods of contraception
Key exclusion criteria (7 listed)
- Subject with any current psychiatric or eating or suicidal attempt disorder, or history of such disorder.
- Subject with any history of chronic GI disorder or disease.
- Subject with any significant active or prior metabolic disorder or disease.
- Subject with any use of probiotic supplements or antibiotics in the previous month.
- Subject with current use of any medications with potential central nervous system effects (antidepressants, anxiolytics, opiate pain medications...).
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)Arm 1 - Intervention 1 (probiotics) | Other | 1 = Tested product |
| 2-Milk-based non-fermented dairy product(control)Arm 2 - Intervention 2 (control) | 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 25 Nov 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 Adult Women, run by Danone Global Research & Innovation Center at 1 site in United States.
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 7 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 25 Nov 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 United States. 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. 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 25 Nov 2016.