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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00517335
Other study ID # R01MH046001
Secondary ID R01MH046001DATR
Status Completed
Phase N/A
First received August 14, 2007
Last updated March 7, 2016
Start date May 2005
Est. completion date January 2008

Study information

Verified date April 2015
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders.


Description:

Eating disorders often result in serious illness and can lead to prolonged health complications, including heart and kidney problems, digestive disorders, nerve damage, and low blood pressure. Anorexia nervosa and bulimia nervosa are examples eating disorders. People with anorexia nervosa do not eat enough in fear of becoming overweight, resulting in extreme weight loss. People with bulimia nervosa first binge by consuming hundreds or even thousands of calories within a very short time period and then purge by either vomiting or using laxatives. Women are at a greater risk of developing the disorders, particularly when they are between the ages of 12 and 24. Treatments for eating disorders typically include nutrition counseling, psychotherapy, and medication. To better understand eating disorders, this study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders.

All participants in this observational study will be administered a taste test to determine if they can consciously differentiate between a sugar solution and an artificially sweetened solution. Participants may also perform several brief computerized tests, ranging from 3 to 10 minutes each, to evaluate thinking, memory, and information processing skills. Participants who cannot tell the difference between the solutions will undergo a functional magnetic resonance imaging (fMRI) scan, which will take pictures of the brain and blood flowing through the brain. Prior to the scan, blood and urine collection may occur, and participants may complete two additional computerized tests. The scan will require 60 to 90 minutes to complete. During the scan, participants will hold two thin tubes in their mouth. At various intervals, these tubes will deliver 1 ml of liquid containing either sugar water or an artificial sweetener into each participant's mouth. A screen projection of abstract pictures will also be shown to each participant throughout the scan, either before the liquid is delivered or alone. This study will require a 6- to 9-hour time commitment. The results from this study may provide valuable information regarding anorexia nervosa and bulimia nervosa and may eventually lead to the development of new and better treatment options for these complex and serious disorders.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Right-handed

- Recovered from anorexia or bulimia nervosa at least 12 months prior to study entry

- Met DSM criteria for anorexia or bulimia nervosa at one time within 3 years prior to study entry

Exclusion Criteria:

- Pregnant or breastfeeding

- Currently taking any medication (except birth control)

- Any current mental illness

- Any metal in body

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Functional magnetic resonance imaging (fMRI) scan
Healthy control women, recovered bulimia women, and also recovered anorexia women will complete specific tasks in an fMRI scanner that will take up to 60 minutes.

Locations

Country Name City State
United States UCSD Eating Disorders Treatment and Research Center La Jolla California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Diego National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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