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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398163
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : November 25, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Adult Women Other: 1-Fermented Dairy Product (test) Other: 2-Milk-based non-fermented dairy product(control) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : April 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398163

United States, California
UCLA - University
Los Angeles, California, United States, 90095-7170
Sponsors and Collaborators
Danone Research

Responsible Party: Danone Research Identifier: NCT01398163     History of Changes
Other Study ID Numbers: NU271
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Danone Research:
digestive well-being
brain-gut axis