Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01398163
First received: July 19, 2011
Last updated: November 23, 2016
Last verified: November 2016
  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 Blind (Subject, 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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01398163     History of Changes
Other Study ID Numbers: NU271 
Study First Received: July 19, 2011
Last Updated: November 23, 2016
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 December 08, 2016