Status:
COMPLETED
A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women
Lead Sponsor:
Danone Global Research & Innovation Center
Conditions:
Healthy Adult Women
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief 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 circui...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01398163
Start Date
April 1 2009
End Date
December 1 2010
Last Update
November 25 2016
Active Locations (1)
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1
UCLA - University
Los Angeles, California, United States, 90095-7170