Eating DisordersNCT00517335
Evaluating the Brain's Response to Natural Versus Artificial Sweetener in Women Who Have Had an Eating Disorder
An observational study of Eating Disorders, run by University of California, San Diego at 1 site in United States.
Trial summary
This study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Functional magnetic resonance imaging (fMRI) scan
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jan 2008
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will include women between the ages of 18 and 45 who have recovered from anorexia or bulimia nervosa for over 1 year and have no current medical problems.
Who may be able to join
- Right-handed
- Recovered from anorexia or bulimia nervosa at least 12 months prior to study entry
- Met DSM criteria for anorexia or bulimia nervosa at one time within 3 years prior to study entry
Who cannot join
- Pregnant or breastfeeding
- Currently taking any medication (except birth control)
- Any current mental illness
- Any metal in body
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Eating Disorders Treatment and Research Center
La Jolla, California, 92037
About this study
Official title: The Evaluation of Brain Neuronal Activity in Response to Natural (Sucrose) and Artificial (Sucralose) Taste Stimuli- Does Caloric Content Matter to the Brain?
This study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders.
Read the detailed description
Eating disorders often result in serious illness and can lead to prolonged health complications, including heart and kidney problems, digestive disorders, nerve damage, and low blood pressure. Anorexia nervosa and bulimia nervosa are examples eating disorders. People with anorexia nervosa do not eat enough in fear of becoming overweight, resulting in extreme weight loss. People with bulimia nervosa first binge by consuming hundreds or even thousands of calories within a very short time period and then purge by either vomiting or using laxatives. Women are at a greater risk of developing the disorders, particularly when they are between the ages of 12 and 24. Treatments for eating disorders typically include nutrition counseling, psychotherapy, and medication. To better understand eating disorders, this study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders.
All participants in this observational study will be administered a taste test to determine if they can consciously differentiate between a sugar solution and an artificially sweetened solution. Participants may also perform several brief computerized tests, ranging from 3 to 10 minutes each, to evaluate thinking, memory, and information processing skills. Participants who cannot tell the difference between the solutions will undergo a functional magnetic resonance imaging (fMRI) scan, which will take pictures of the brain and blood flowing through the brain. Prior to the scan, blood and urine collection may occur, and participants may complete two additional computerized tests. The scan will require 60 to 90 minutes to complete. During the scan, participants will hold two thin tubes in their mouth. At various intervals, these tubes will deliver 1 ml of liquid containing either sugar water or an artificial sweetener into each participant's mouth. A screen projection of abstract pictures will also be shown to each participant throughout the scan, either before the liquid is delivered or alone. This study will require a 6- to 9-hour time commitment. The results from this study may provide valuable information regarding anorexia nervosa and bulimia nervosa and may eventually lead to the development of new and better treatment options for these complex and serious disorders.
- Conditions
- Eating Disorders
- Being tested
- Functional magnetic resonance imaging (fMRI) scan
- Keywords
- anorexia nervosa, bulimia nervosa
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging (fMRI) scanProcedure or surgery
Also called Neurobiology of Eating Disorders, fMRI imaging of Anorexia and Bulimia Nervosa
Healthy control women, recovered bulimia women, and also recovered anorexia women will complete specific tasks in an fMRI scanner that will take up to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women who are healthy controls Receives: Procedure: Functional magnetic resonance imaging (fMRI) scan | |
| 2 | Women who have recovered from bulimia Receives: Procedure: Functional magnetic resonance imaging (fMRI) scan | |
| 3 | Women who have recovered from anorexia Receives: Procedure: Functional magnetic resonance imaging (fMRI) scan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startMay 2005
- Primary completionJan 2008
- Study completionJan 2008
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.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Watler Kaye, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517335
- Sponsor's protocol ID
- R01MH046001
- Other IDs
- R01MH046001, DATR A3-NSS
- Status last verified
- Apr 2015
- First submitted
- 14 Aug 2007
- Last updated
- 8 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Brain Neuronal Activity in Response to Natural (Sucrose) and Artificial (Sucralose) Taste Stimuli- Does Caloric Content Matter to the Brain?
- ClinicalTrials.gov ID
- NCT00517335
- Acronym / sponsor ID
- R01MH046001
- Conditions
- Eating Disorders
- Keywords
- anorexia nervosa, bulimia nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Aug 2007 (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 compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders.
Detailed description
Eating disorders often result in serious illness and can lead to prolonged health complications, including heart and kidney problems, digestive disorders, nerve damage, and low blood pressure. Anorexia nervosa and bulimia nervosa are examples eating disorders. People with anorexia nervosa do not eat enough in fear of becoming overweight, resulting in extreme weight loss. People with bulimia nervosa first binge by consuming hundreds or even thousands of calories within a very short time period and then purge by either vomiting or using laxatives. Women are at a greater risk of developing the disorders, particularly when they are between the ages of 12 and 24. Treatments for eating disorders typically include nutrition counseling, psychotherapy, and medication. To better understand eating disorders, this study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders.
All participants in this observational study will be administered a taste test to determine if they can consciously differentiate between a sugar solution and an artificially sweetened solution. Participants may also perform several brief computerized tests, ranging from 3 to 10 minutes each, to evaluate thinking, memory, and information processing skills. Participants who cannot tell the difference between the solutions will undergo a functional magnetic resonance imaging (fMRI) scan, which will take pictures of the brain and blood flowing through the brain. Prior to the scan, blood and urine collection may occur, and participants may complete two additional computerized tests. The scan will require 60 to 90 minutes to complete. During the scan, participants will hold two thin tubes in their mouth. At various intervals, these tubes will deliver 1 ml of liquid containing either sugar water or an artificial sweetener into each participant's mouth. A screen projection of abstract pictures will also be shown to each participant throughout the scan, either before the liquid is delivered or alone. This study will require a 6- to 9-hour time commitment. The results from this study may provide valuable information regarding anorexia nervosa and bulimia nervosa and may eventually lead to the development of new and better treatment options for these complex and serious disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Functional magnetic resonance imaging (fMRI) scanWomen who are healthy controls |
| 2 | – | Procedure: Functional magnetic resonance imaging (fMRI) scanWomen who have recovered from bulimia |
| 3 | – | Procedure: Functional magnetic resonance imaging (fMRI) scanWomen who have recovered from anorexia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include women between the ages of 18 and 45 who have recovered from anorexia or bulimia nervosa for over 1 year and have no current medical problems.
Key inclusion criteria (3 listed)
- Right-handed
- Recovered from anorexia or bulimia nervosa at least 12 months prior to study entry
- Met DSM criteria for anorexia or bulimia nervosa at one time within 3 years prior to study entry
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Currently taking any medication (except birth control)
- Any current mental illness
- Any metal in body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imaging (fMRI) scanAlso: Neurobiology of Eating Disorders, fMRI imaging of Anorexia and Bulimia NervosaHealthy control women, recovered bulimia women, and also recovered anorexia women will complete specific tasks in an fMRI scanner that will take up to 60 minutes. | Procedure or surgery | 1, 2, 3 |
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 8 Mar 2016.
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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.
Watler Kaye, MD principal investigator
University of California, San Diego
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 University of California, San Diego 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 3 inclusion and 4 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 8 Mar 2016. 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 8 Mar 2016.