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Determining the Response to Sipping Beverages Without Swallowing in People With Eating Disorders

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ClinicalTrials.gov Identifier: NCT00353548
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : July 23, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date July 14, 2006
First Posted Date July 18, 2006
Last Update Posted Date July 23, 2012
Study Start Date April 2005
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00353548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determining the Response to Sipping Beverages Without Swallowing in People With Eating Disorders
Official Title 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.
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Eating Disorders
Intervention Not Provided
Study Groups/Cohorts
  • 1-Anorexia Nervosa
    Women ages 16-50 who meet DSM-IV criteria for anorexia nervosa
  • 2-Bulimia Nervosa
    Women age 16-50 who meet DSM-IV criteria for bulimia nervosa
  • 3-Binge Eating Disorder
    Women with binge eating disorder
  • 4-Healthy Controls
    Healthy control subjects ages 16-50 of normal weight
  • 5-Obese Controls
    Healthy obese control subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 14, 2011)
80
Original Enrollment
 (submitted: July 14, 2006)
150
Actual Study Completion Date July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00353548
Other Study ID Numbers #5046/#6158R
K23MH071285-01 ( U.S. NIH Grant/Contract )
DATR AK-TNAI1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor New York State Psychiatric Institute
Collaborators National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Diane A. Klein, MD Columbia University Department of Psychiatry/New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date July 2012