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Evaluating the Brain's Response to Natural Versus Artificial Sweetener in Women Who Have Had an Eating Disorder

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00517335
  Purpose

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.


Condition Intervention
Eating Disorders
Procedure: Functional magnetic resonance imaging (fMRI) scan

MedlinePlus related topics:   Eating Disorders   

ChemIDplus related topics:   Sucrose   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   The Evaluation of Brain Neuronal Activity in Response to Natural (Sucrose) and Artificial (Sucralose) Taste Stimuli- Does Caloric Content Matter to the Brain?

Further study details as provided by National Institute of Mental Health (NIMH):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

If desired subjects have a chance to be a part of a DNA blood draw aspect of the study


Estimated Enrollment:   60
Study Start Date:   May 2005
Study Completion Date:   January 2008
Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Women who are healthy controls
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.
2
Women who have recovered from bulimia
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.
3
Women who have recovered from anorexia
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.

Detailed 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.

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

The study will include women between the ages of 18 and 45 who have recovered from anorexia or bulimia nervosa for over 1 year and have no current medical problems.


Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517335

Locations
United States, California
UCSD Eating Disorders Treatment and Research Center    
      La Jolla, California, United States, 92037

Sponsors and Collaborators

Investigators
Principal Investigator:     Watler Kaye, MD     University of California, San Diego (UCSD)    
  More Information


Responsible Party:   University of California San Diego ( Walter Kaye, MD Professor of Psychiatry )
Study ID Numbers:   R01 MH46001, DATR A3-NSS
First Received:   August 14, 2007
Last Updated:   March 26, 2008
ClinicalTrials.gov Identifier:   NCT00517335
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
anorexia nervosa  
bulimia nervosa  

Study placed in the following topic categories:
Bulimia Nervosa
Mental Disorders
Bulimia
Anorexia
Anorexia Nervosa
Eating Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 07, 2008




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