Determining the Response to Sipping Beverages Without Swallowing in People With Eating Disorders
NCT ID: NCT00353548
Last Updated: 2012-07-23
Study Results
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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COMPLETED
80 participants
OBSERVATIONAL
2005-04-30
2011-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1-Anorexia Nervosa
Women ages 16-50 who meet DSM-IV criteria for anorexia nervosa
No interventions assigned to this group
2-Bulimia Nervosa
Women age 16-50 who meet DSM-IV criteria for bulimia nervosa
No interventions assigned to this group
3-Binge Eating Disorder
Women with binge eating disorder
No interventions assigned to this group
4-Healthy Controls
Healthy control subjects ages 16-50 of normal weight
No interventions assigned to this group
5-Obese Controls
Healthy obese control subjects
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
45 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Diane A. Klein, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University Department of Psychiatry/New York State Psychiatric Institute
Locations
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New York State Psychiatric Institute/Columbia University Medical Center
New York, New York, United States
Countries
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Other Identifiers
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DATR AK-TNAI1
Identifier Type: -
Identifier Source: secondary_id
#5046/#6158R
Identifier Type: -
Identifier Source: org_study_id