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

NCT ID: NCT01398163

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Adult Women

Keywords

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probiotics digestive well-being fMRI brain-gut axis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Tested product

Group Type EXPERIMENTAL

1-Fermented Dairy Product (test)

Intervention Type OTHER

Arm 1 - Intervention 1 (probiotics)

2 = Control product

Group Type ACTIVE_COMPARATOR

2-Milk-based non-fermented dairy product(control)

Intervention Type OTHER

Arm 2 - Intervention 2 (control)

3 = No product

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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1-Fermented Dairy Product (test)

Arm 1 - Intervention 1 (probiotics)

Intervention Type OTHER

2-Milk-based non-fermented dairy product(control)

Arm 2 - Intervention 2 (control)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA - University

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NU271

Identifier Type: -

Identifier Source: org_study_id