Eating DisordersNCT00353548
Determining the Response to Sipping Beverages Without Swallowing in People With Eating Disorders
An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women with anorexia nervosa, bulimia nervosa, and binge eating disorder as well as gender, age, and weight-matched control participants.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute/Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Study of Response to the Taste of Beverages That Are Not Swallowed (Sipping and Spitting in Eating Disorders)
This study will use a sipping and spitting exercise to better understand the brain's response to food intake in people with eating disorders.
Read the 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.
- Conditions
- Eating Disorders
- Keywords
- Bulimia Nervosa, Binge Eating Disorder, Obesity, Anorexia Nervosa
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder, Obesity, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startApr 2005
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Diane A. Klein, MD, Principal investigator, Columbia University Department of Psychiatry/New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353548
- Sponsor's protocol ID
- #5046/#6158R
- Other IDs
- K23MH071285-01, DATR AK-TNAI1
- Status last verified
- Jul 2012
- First submitted
- 14 Jul 2006
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Response to the Taste of Beverages That Are Not Swallowed (Sipping and Spitting in Eating Disorders)
- ClinicalTrials.gov ID
- NCT00353548
- Acronym / sponsor ID
- #5046/#6158R
- Conditions
- Eating Disorders
- Keywords
- Bulimia Nervosa, Binge Eating Disorder, Obesity, Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women with anorexia nervosa, bulimia nervosa, and binge eating disorder as well as gender, age, and weight-matched control participants.
Key inclusion criteria (14 listed)
- Meets DSM-IV criteria for bulimia nervosa
- Duration of illness is 1 year
- Self-induces vomiting
- Weighs between 85 and 120% of ideal weight
- Meets DSM-IV criteria for anorexia nervosa (amenorrhea will not be required for study inclusion)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane A. Klein, MD principal investigator
Columbia University Department of Psychiatry/New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2012.