Skip to main content
OpenTrials
Completed

NCT Number: NCT01398163

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Adult Women

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCLA - University

Los Angeles, California, 90095-7170, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1-Fermented Dairy Product (test)

Other

Arm 1 - Intervention 1 (probiotics)

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

Other

Arm 2 - Intervention 2 (control)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 20, 2011
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.