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

A f-MRI STUDY OF AFFECTIVE CHANGES ASSOCIATED WITH FOUR WEEKS CONSUMPTION OF A FERMENTED DAIRY PRODUCT IN HEALTHY WOMEN

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Women
• Intervention / Treatment: Other: 1-Fermented Dairy Product (test); Other: 2-Milk-based non-fermented dairy product(control)

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-7170
      • UCLA - University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 = Tested product	Other: 1-Fermented Dairy Product (test); Arm 1 - Intervention 1 (probiotics)
Active Comparator: 2 = Control product	Other: 2-Milk-based non-fermented dairy product(control); Arm 2 - Intervention 2 (control)
No Intervention: 3 = No product

Collaborators and Investigators

• Sponsor: Danone Research

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): November 25, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: probiotics; fMRI; brain-gut axis; digestive well-being
• Other Study ID Numbers: NU271