A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women

Danone

Status

Completed

Conditions

Healthy Adult Women

Treatments

Other: 2-Milk-based non-fermented dairy product(control)

Other: 1-Fermented Dairy Product (test)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01398163

NU271

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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