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
• Interventions: Other: 1-Fermented Dairy Product (test); Other: 2-Milk-based non-fermented dairy product(control)

• 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

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

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

Arm && Interventions

Group	Intervention	Description
1 = Tested product	1-Fermented Dairy Product (test)	-
2 = Control product	2-Milk-based non-fermented dairy product(control)	-

Trial Locations

Locations (1)

UCLA - University; 🇺🇸 Los Angeles, California, United States