Healthy Adult Women
Conditions
Keywords
probiotics, digestive well-being, fMRI, brain-gut axis
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.
Interventions
Arm 1 - Intervention 1 (probiotics)
Arm 2 - Intervention 2 (control)
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Countries
United States
Outcome results
None listed