Determining the Response to Sipping Beverages Without Swallowing in People With Eating Disorders
Tracking Information | |||||
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First Received Date ICMJE | July 14, 2006 | ||||
Last Updated Date | July 20, 2012 | ||||
Start Date ICMJE | April 2005 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
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Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00353548 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Determining the Response to Sipping Beverages Without Swallowing in People With Eating Disorders | ||||
Official Title ICMJE | Study of Response to the Taste of Beverages That Are Not Swallowed (Sipping and Spitting in Eating Disorders) | ||||
Brief Summary | This study will use a sipping and spitting exercise to better understand the brain's response to food intake in people with eating disorders. |
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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. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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Biospecimen | |||||
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. |
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Condition ICMJE | Eating Disorders | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 80 | ||||
Completion Date | July 2011 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: For participants with bulimia nervosa:
For participants with anorexia nervosa:
For participants with binge eating disorder:
For healthy participants:
Exclusion Criteria: For participants with anorexia nervosa, bulimia nervosa, or binge eating disorder:
For healthy participants:
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Gender | Female | ||||
Ages | 16 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00353548 | ||||
Other Study ID Numbers ICMJE | #5046/#6158R, K23MH071285-01, DATR AK-TNAI1 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | New York State Psychiatric Institute | ||||
Study Sponsor ICMJE | New York State Psychiatric Institute | ||||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
Investigators ICMJE |
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Information Provided By | New York State Psychiatric Institute | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |