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:
Collaborator:
University of California, Los Angeles
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01398163
First received: July 19, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  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)
Other: 3 - No product

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

Estimated Enrollment: 45
Study Start Date: April 2009
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 - Intervential 2 (control)
No Intervention: 3 = No product Other: 3 - No product
Arm 3 - Intervention 3 (no product)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398163

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

No publications provided

ClinicalTrials.gov Identifier: NCT01398163     History of Changes
Other Study ID Numbers: NU271
Study First Received: July 19, 2011
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014