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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01398163
First Posted: July 20, 2011
Last Update Posted: November 25, 2016
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.
Information provided by (Responsible Party):
Danone Research
  Purpose
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 Intervention
Healthy Adult Women Other: 1-Fermented Dairy Product (test) Other: 2-Milk-based non-fermented dairy product(control)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A f-MRI STUDY OF AFFECTIVE CHANGES ASSOCIATED WITH FOUR WEEKS CONSUMPTION OF A FERMENTED DAIRY PRODUCT IN HEALTHY WOMEN

Further study details as provided by Danone Research:

Enrollment: 51
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01398163


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

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01398163     History of Changes
Other Study ID Numbers: NU271
First Submitted: July 19, 2011
First Posted: July 20, 2011
Last Update Posted: November 25, 2016
Last Verified: November 2016

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