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:
Danone Research
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 June 17, 2013