Anorexia NervosaNCT04626219
Neurobiology of Anorexia and Bulimia Nervosa
A study testing Imaging, fast and regulated meals in people with Anorexia Nervosa and Bulimia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to investigate areas of the brain responsible for appetite regulation. More specifically, the investigators would like to study changes in brain activation, e.g., changes in blood flow and oxygen use of the brain, during two different states: Once when the participants are hungry, and once… 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
- Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Imaging, fast and regulated meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2014
- Phase
- Interventional
- 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
Who may be able to join
- Must have had a DSM-IV diagnosis of anorexia or bulimia nervosa
- The onset of their illness must have been at least 4 years prior to participating in this study
- Must have recovered for 12 months or more prior to entering the study.
Who cannot join
- Met diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study.
- Current diagnosis of a severe major affective or anxiety disorder or presence of other psychopathology that might interfere with ability to participate in the study.
- Organic brain syndromes, dementia, psychotic disorders or mental retardation
- Neurological or medical disorders
- Use of psychoactive medication in the 3 months prior to the study.
- Pregnancy or lactation, lack of effective birth control during 15 days before the scans.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD General Clinical Research Center
San Diego, California, 92103
About this study
The purpose of this study is to investigate areas of the brain responsible for appetite regulation. More specifically, the investigators would like to study changes in brain activation, e.g., changes in blood flow and oxygen use of the brain, during two different states: Once when the participants are hungry, and once when the participants are not hungry. The aim is to find out more about the neurobiology of Anorexia and Bulimia Nervosa by comparing women who never had an eating disorder with women who have recovered from Anorexia or Bulimia Nervosa.
Read the detailed description
The main goal of this study is to explore the effects of hunger and satiety on regions in our brain in order to better understand the pathophysiology underlying restricted eating in anorexics, and overeating in women with Bulimia Nervosa. The investigators will adopt a paradigm that will model, in the laboratory, the naturalistic extremes of dietary intake practiced by women recovered from Anorexia or Bulimia Nervosa by comparing a hungry state (21-hour fast) to a satiated state (21-hour when fed). They may share an inability to precisely modulate emotionality and reward in response to salient stimuli, such as food. However, they may differ in terms of function of other pathways.
The incentive motivational drive to seek and consume food is a complex process, deriving from interrelated psychobiological factors including food's rewarding properties, an individual's homeostatic needs and cognitive ability to favor alternative behaviors. In order to examine how these factors may contribute to dysregulated feeding behavior in women recovered from Anorexia or Bulimia Nervosa, the investigators will explore measures of 1) anxiety; 2) cognitive inhibition and dysinhibition; and 3) reward.
Subjects will also be asked to undergo a Magnetic Resonance Imaging (MRI) scan of their head. This scan uses powerful magnetic fields. The magnetic fields temporarily magnetize some of the chemicals in our brain and this allows a scanner and a computer to take a very detailed picture of the structure of our brain. During the MRI, the participants will be asked to lie quietly inside the center of a large, doughnut shaped magnet for approximately 30 minutes. The participant's head will be placed in a special, helmet-like "head-holder" to help them to keep their head still. This part of the study will take place on the same day prior to the first PET scan. In this protocol, only one MRI will be done. In subjects with a questionable history of metallic fragments, an x-ray of the suspected body area will be performed before the MRI to make sure the participants have no metal fragments in their body.
In addition to fMRI scanning there are a few other tests that will be administered. This includes a Pre Study Taste Test, in order to prepare them for the fMRI taste task. Participants will be presented five solutions of sucrose (2, 4, 8, 16 and 32 weight by volume) and will then be asked to rate the pleasantness of each solution using a standard seven-point preference scale (i.e., 1=extremely dislike; 7= extremely like). They will also rate perceived sweetness of each solution using a seven-point category scale (i.e., 1=absent; 7=extreme). In addition, they will be presented variants of a tasteless solution Study participants will be asked to choose the solution that has the least taste and this solution will then be used during fMRI scanning.
The study takes place over the span of 4 consecutive days on location at the General Clinical Research Center (GCRC) at the University of California in San Diego. During day 1 of the study, lab work would be completed in the morning and several computerized and paper and pencil tasks in the afternoon. Starting at noon of Day 2 and Day 3 of the study, subject participants will undergo two identical 21-hour cycles. In one cycle, study participants will refrain from eating after lunch at 12 noon until 9 a.m. the next morning and they will engage in fMRI studies from 9 to 10:30 a.m. In the other cycle they will be given a standardized diet from noon until 9 a.m. the next day and engage in fMRI studies from 9 to10:30 a.m. The sequence of the two cycles will be randomized across subjects. Caloric consumption will also be regulated. All subjects will receive exactly the same menu over the 4 days of the study. They will eat only when at the GCRC and only when monitored by the GCRC staff. The total daily energy requirement will be calculated as 30 kcal/kg body weight per day with a 53% carbohydrate, 32% fat, 15% protein diet. Water will be provided with the amount consumed recorded. Subjects will be allowed to consume their usual amounts of caffeinated beverages but not allowed to use artificial or natural sweeteners or cream.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Being tested
- Imaging, fast, regulated meals
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingOther
Imaging - Magnetic Resonance Imaging (MRI) scan of their heads
fastBehavioural
hungry state - refrain from eating after lunch at 12 noon until 9 a.m. the next morning
regulated mealsBehavioural
standardized diet from noon until 9 a.m. the next day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Period of 12 hours where participants eat regulated meals Receives: Other: Imaging; Behavioral: regulated meals |
| 2 | Experimental | Period of 12 hours where participants do not eat anything Receives: Other: Imaging; Behavioral: fast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior insula (AI) and orbital frontal cortex (OFC) response to sucrose(relative to ionic water)
fMRI BOLD response
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study startFeb 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Kaye, University of California, San Diego
- Investigators
- Walter Kaye, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626219
- Sponsor's protocol ID
- 080019
- Status last verified
- Nov 2020
- First submitted
- 23 Feb 2009
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiology of Anorexia and Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT04626219
- Acronym / sponsor ID
- 080019
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 12 Nov 2020 (actual)
- 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.
The purpose of this study is to investigate areas of the brain responsible for appetite regulation. More specifically, the investigators would like to study changes in brain activation, e.g., changes in blood flow and oxygen use of the brain, during two different states: Once when the participants are hungry, and once when the participants are not hungry. The aim is to find out more about the neurobiology of Anorexia and Bulimia Nervosa by comparing women who never had an eating disorder with women who have recovered from Anorexia or Bulimia Nervosa.
Detailed description
The main goal of this study is to explore the effects of hunger and satiety on regions in our brain in order to better understand the pathophysiology underlying restricted eating in anorexics, and overeating in women with Bulimia Nervosa. The investigators will adopt a paradigm that will model, in the laboratory, the naturalistic extremes of dietary intake practiced by women recovered from Anorexia or Bulimia Nervosa by comparing a hungry state (21-hour fast) to a satiated state (21-hour when fed). They may share an inability to precisely modulate emotionality and reward in response to salient stimuli, such as food. However, they may differ in terms of function of other pathways.
The incentive motivational drive to seek and consume food is a complex process, deriving from interrelated psychobiological factors including food's rewarding properties, an individual's homeostatic needs and cognitive ability to favor alternative behaviors. In order to examine how these factors may contribute to dysregulated feeding behavior in women recovered from Anorexia or Bulimia Nervosa, the investigators will explore measures of 1) anxiety; 2) cognitive inhibition and dysinhibition; and 3) reward.
Subjects will also be asked to undergo a Magnetic Resonance Imaging (MRI) scan of their head. This scan uses powerful magnetic fields. The magnetic fields temporarily magnetize some of the chemicals in our brain and this allows a scanner and a computer to take a very detailed picture of the structure of our brain. During the MRI, the participants will be asked to lie quietly inside the center of a large, doughnut shaped magnet for approximately 30 minutes. The participant's head will be placed in a special, helmet-like "head-holder" to help them to keep their head still. This part of the study will take place on the same day prior to the first PET scan. In this protocol, only one MRI will be done. In subjects with a questionable history of metallic fragments, an x-ray of the suspected body area will be performed before the MRI to make sure the participants have no metal fragments in their body.
In addition to fMRI scanning there are a few other tests that will be administered. This includes a Pre Study Taste Test, in order to prepare them for the fMRI taste task. Participants will be presented five solutions of sucrose (2, 4, 8, 16 and 32 weight by volume) and will then be asked to rate the pleasantness of each solution using a standard seven-point preference scale (i.e., 1=extremely dislike; 7= extremely like). They will also rate perceived sweetness of each solution using a seven-point category scale (i.e., 1=absent; 7=extreme). In addition, they will be presented variants of a tasteless solution Study participants will be asked to choose the solution that has the least taste and this solution will then be used during fMRI scanning.
The study takes place over the span of 4 consecutive days on location at the General Clinical Research Center (GCRC) at the University of California in San Diego. During day 1 of the study, lab work would be completed in the morning and several computerized and paper and pencil tasks in the afternoon. Starting at noon of Day 2 and Day 3 of the study, subject participants will undergo two identical 21-hour cycles. In one cycle, study participants will refrain from eating after lunch at 12 noon until 9 a.m. the next morning and they will engage in fMRI studies from 9 to 10:30 a.m. In the other cycle they will be given a standardized diet from noon until 9 a.m. the next day and engage in fMRI studies from 9 to10:30 a.m. The sequence of the two cycles will be randomized across subjects. Caloric consumption will also be regulated. All subjects will receive exactly the same menu over the 4 days of the study. They will eat only when at the GCRC and only when monitored by the GCRC staff. The total daily energy requirement will be calculated as 30 kcal/kg body weight per day with a 53% carbohydrate, 32% fat, 15% protein diet. Water will be provided with the amount consumed recorded. Subjects will be allowed to consume their usual amounts of caffeinated beverages but not allowed to use artificial or natural sweeteners or cream.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Imaging, Behavioral: regulated mealsPeriod of 12 hours where participants eat regulated meals |
| 2 | Experimental | Other: Imaging, Behavioral: fastPeriod of 12 hours where participants do not eat anything |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have had a DSM-IV diagnosis of anorexia or bulimia nervosa
- The onset of their illness must have been at least 4 years prior to participating in this study
- Must have recovered for 12 months or more prior to entering the study.
Key exclusion criteria (6 listed)
- Met diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study.
- Current diagnosis of a severe major affective or anxiety disorder or presence of other psychopathology that might interfere with ability to participate in the study.
- Organic brain syndromes, dementia, psychotic disorders or mental retardation
- Neurological or medical disorders
- Use of psychoactive medication in the 3 months prior to the study.
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 |
|---|---|---|
| ImagingImaging - Magnetic Resonance Imaging (MRI) scan of their heads | Other | 1, 2 |
| fasthungry state - refrain from eating after lunch at 12 noon until 9 a.m. the next morning | Behavioural | 2 |
| regulated mealsstandardized diet from noon until 9 a.m. the next day | Behavioural | 1 |
Primary outcome
Anterior insula (AI) and orbital frontal cortex (OFC) response to sucrose(relative to ionic water)
Time frame: 5 years
fMRI BOLD response
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 12 Nov 2020.
- Related InfoLink provided by the sponsor.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
Walter Kaye, M.D. 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?
A study testing Imaging, fast and regulated meals in people with Anorexia Nervosa and Bulimia Nervosa, 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 6 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 12 Nov 2020. 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.
What does the primary outcome measure?
Anterior insula (AI) and orbital frontal cortex (OFC) response to sucrose(relative to ionic water) (time frame: 5 years). It is what the study was designed to measure, not a finding.
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 12 Nov 2020.