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Determining the Response to Sipping Beverages Without Swallowing in People With Eating Disorders
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00353548
  Purpose

This study will use a sipping and spitting exercise to better understand the brain's response to food intake in people with eating disorders.


Condition
Eating Disorders

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Study of Response to the Taste of Beverages That Are Not Swallowed (Sipping and Spitting in Eating Disorders)

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

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 150
Study Start Date: April 2005
Groups/Cohorts
1
Women with anorexia nervosa
2
Women with bulimia nervosa
3
Women with binge eating disorder
4
Healthy control subjects of normal weight
5
Healthy obese control subjects

Detailed Description:

Eating behavior is controlled by many factors, including appetite; food availability; family, peer, and cultural practices; and attempts at voluntary control. Eating disorders are characterized by a voluntary control of eating behavior, causing serious disturbances in normal eating habits. People with eating disorders demonstrate an extreme and unhealthy reduction or increase in food intake, as well as feelings of distress or extreme concern about body shape or weight. The three most common types of eating disorders are anorexia nervosa, bulimia nervosa, and binge eating disorder. People with anorexia nervosa have an intense fear of gaining weight or becoming fat. They are usually underweight, and resist maintaining a body weight at or above the minimum normal weight for their age and height. People with bulimia nervosa are less frequently underweight. Their eating habits are characterized by episodes of bingeing, followed by episodes of purging. Similarly, people with binge eating disorder have eating habits characterized by episodes of binge eating, but no purging. Studies on the basic biology of appetite control and the effects of overeating and starvation have revealed extensive information about eating disorders, but there are still questions to be answered. This study will use a sipping and spitting exercise to better understand the brain's response to food intake in people with eating disorders.

Participants in this observational study will first report to the Biological Studies Unit (BSU) for a screening visit. Participants will be provided with a series of sweetened beverages to taste and spit out. The beverages will be made with water, Kool-Aid mix, and sugar or artificial sweetener. Participants will rate the sweetness of each beverage and how much they like it. They will then practice sipping the beverage through a straw and spitting it out without swallowing. Those participants who feel comfortable with the sipping and spitting exercise will report to the BSU for 10 sipping and spitting exercises. The exercises may be scheduled on up to 4 separate days, and may last up to 2 hours per day. Participants will eat a standardized breakfast on the morning of the study, and then will not eat again until they report to the BSU 4 hours later. Participants will sit alone in a room alone, and sip and spit beverages for up to 5 minutes at a time. Between sipping and spitting sessions, participants will complete surveys about hunger and other sensations. They will also rinse their mouths out with baking soda and water to clear the taste of the previous beverage and to prevent discoloration of the mouth from the Kool-Aid. Measurements will include the amount of beverage sipped at a time, and how quickly each was sipped.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with anorexia nervosa, bulimia nervosa, and binge eating disorder as well as gender, age, and weight-matched control participants.

Criteria

Inclusion Criteria:

For participants with bulimia nervosa:

  • Meets DSM-IV criteria for bulimia nervosa
  • Duration of illness is 1 year
  • Self-induces vomiting
  • Weighs between 85 and 120% of ideal weight

For participants with anorexia nervosa:

  • Meets DSM-IV criteria for anorexia nervosa (amenorrhea will not be required for study inclusion)
  • Medically stable

For participants with binge eating disorder:

  • Meets DSM-IV criteria for binge eating disorder
  • Duration of illness is 1 year
  • Body Mass Index (BMI) is at least 30

For healthy participants:

  • Weighs between 80 and 120% of ideal weight

Exclusion Criteria:

For participants with anorexia nervosa, bulimia nervosa, or binge eating disorder:

  • Significant medical illness
  • At risk for suicide
  • Currently taking medication
  • History of drug or alcohol abuse within 6 months prior to study entry
  • Pregnant or breastfeeding
  • Axis I psychiatric disorder requiring pharmacotherapy
  • Axis I psychiatric disorder that could impair ability to participate in the study (e.g., mania, psychosis)
  • Comorbid binge eating disorder and an Axis I illness other than major depression

For healthy participants:

  • Current or history of psychiatric illness
  • History of any eating disorder
  • Significant medical illness
  • Currently taking medication
  • History of drug or alcohol abuse within 6 months prior to study entry
  • Pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353548

Contacts
Contact: Marina Gershkovich, BA 212-543-5130 edru@pi.cpmc.columbia.edu

Locations
United States, New York
New York State Psychiatric Institute/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Diane A. Klein, MD Columbia University Department of Psychiatry/New York State Psychiatric Institute
  More Information

Responsible Party: The New York State Psychiatric Institute ( B. Timothy Walsh, MD )
Study ID Numbers: K23 MH71285, DATR AK-TNAI1
Study First Received: July 14, 2006
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00353548  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Bulimia Nervosa
Binge Eating Disorder
Obesity
Anorexia Nervosa

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

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009