A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women
Not Applicable
Completed
- Conditions
- Healthy Adult Women
- Registration Number
- NCT01398163
- Lead Sponsor
- Danone Research
- 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 circuits regulating the subjective experience of emotional valence and digestive well-being.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link probiotics in fermented dairy to emotional valence regulation in healthy women?
How does probiotic consumption compare to standard therapies in modulating brain activity related to emotional valence and digestive well-being?
Which biomarkers correlate with affective changes in response to probiotic intake in NCT01398163?
What adverse events are associated with long-term probiotic use in healthy populations and how are they managed?
How do probiotic strains in this trial interact with gut-brain axis pathways compared to other fermented food interventions?
Trial Locations
- Locations (1)
UCLA - University
🇺🇸Los Angeles, California, United States
UCLA - University🇺🇸Los Angeles, California, United States