MRI Study of Eating Behavior for Bulimia

Overseen By Riley Macks

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Medical instability, Shift work, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 days

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.

Do I need to stop taking my current medications to join the trial?

The trial excludes participants with ongoing medical treatment that may interfere with the study, so you might need to stop certain medications. It's best to discuss your specific medications with the trial team.

Is MRI safe for studying eating behavior in bulimia?

MRI is generally considered safe for studying brain activity and structure, as it is a non-invasive imaging technique that does not use radiation. ^{1 2 3 4 5}

How does this MRI-based treatment for bulimia differ from other treatments?

This MRI-based treatment for bulimia is unique because it focuses on understanding and potentially altering brain activity related to eating behaviors, using imaging techniques to explore neural pathways involved in hunger, satiety, and reward systems. Unlike traditional treatments that may focus on behavioral therapy or medication, this approach aims to identify and address the underlying brain mechanisms contributing to bulimia. ^{2 4 5 6 7}

What data supports the effectiveness of the treatment Fasting state, Fed state, Magnetic Resonance Imaging, Lumakras, Vectibix for bulimia?

Research shows that brain imaging techniques like MRI can help understand the brain changes in bulimia, which might be useful in developing new treatments. However, there is no direct evidence supporting the effectiveness of Lumakras or Vectibix for bulimia, as these drugs are typically used for other conditions. ^{1 2 4 5 7}

Who Is on the Research Team?

Laura A Berner, Ph.D.

Principal Investigator

Mount Sinai Icahn School of Medicine

Are You a Good Fit for This Trial?

This trial is for right-handed, English-speaking females aged 18-45 with a BMI between 18.5 and under 30 who meet the criteria for bulimia nervosa. It's not suitable for those medically unstable, on ongoing treatment, doing shift work, pregnant or lactating, allergic to meal ingredients used in the study, or unable to undergo an fMRI.

Inclusion Criteria

Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2

Right-handed

I am female.

Exclusion Criteria

Shift work

Pregnancy, planned pregnancy, or lactation during the study period

Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fMRI scans after fasting and after a standardized meal to assess neural activation related to cognitive control in bulimia nervosa

2 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in binge-eating, dietary restriction, and compensatory behaviors

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fasting state
• Fed state
• Magnetic Resonance Imaging

Trial Overview The study examines how eating affects decision-making and self-control in women with bulimia nervosa by comparing their brain activity before and after eating using MRI scans while they are in fasting and fed states.

How Is the Trial Designed?

Group I: Participants with Bulimia Nervosa Experimental Treatment 3 Interventions

Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.

Group II: Participants without Bulimia Nervosa Active Control 3 Interventions

Participants are randomly assigned (in even numbers across the two groups) to scan order: A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day. B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 31 patients with bulimia nervosa (BN) and 28 healthy controls, BN patients showed increased gray matter volume in the left medial orbitofrontal cortex (mOFC), indicating structural brain changes associated with the disorder.

The study also found altered resting-state functional connectivity (rsFC) in BN patients, with increased connectivity between the mOFC and visual processing areas, which may relate to body image perception and eating behaviors, highlighting the mOFC's role in the neurobiology of BN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered gray matter volume and functional connectivity in medial orbitofrontal cortex of bulimia nervosa patients: A combined VBM and FC study. Li, WH., Tang, LR., Wang, M., et al.[2022]

Women with bulimia nervosa exhibited reduced brain activation in response to food intake and anticipated food compared to healthy controls, suggesting a potential dysfunction in the brain's reward system.

This hypofunctioning may contribute to binge eating behaviors as individuals with bulimia nervosa might seek to compensate for a lack of reward from food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reward abnormalities among women with full and subthreshold bulimia nervosa: a functional magnetic resonance imaging study. Bohon, C., Stice, E.[2022]

Women with bulimia nervosa (BN) showed decreased white matter integrity, particularly in areas related to taste and reward processing, indicating potential disruptions in brain functionality associated with the disorder.

In contrast to control women, BN women did not exhibit a correlation between white matter integrity and anxiety traits, suggesting that altered white matter functionality may contribute to anxiety in bulimia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

White matter integrity is reduced in bulimia nervosa. Mettler, LN., Shott, ME., Pryor, T., et al.[2021]

fMRI studies of anorexia nervosa reveal that increased amygdala activation is linked to a heightened fear of weight gain, while prefrontal cortex activity is associated with cognitive flexibility.

In bulimic eating disorders, research indicates that the brain's reward system is connected to overeating behaviors, and prefrontal cortex activity relates to impulse control, highlighting the neural mechanisms underlying these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive function in eating disorders]. Okamoto, Y.[2015]

The test-retest reliability of fMRI responses to food-related tasks was found to be poor, with average reliability scores (ICC values) ranging from 0.07 to 0.20, indicating inconsistent results across repeated measures.

Despite some regions showing moderate to good reliability in specific studies, the overall findings highlight the need for standardized fMRI tasks in obesity and eating disorder research to ensure more reliable neural activation measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reliability of functional MRI food receipt, anticipated receipt, and picture tasks. Yokum, S., Bohon, C., Berkman, E., et al.[2023]

In a study involving 43 patients with bulimia nervosa and 31 healthy controls, significant microstructural changes in white matter were observed, particularly decreased fractional anisotropy in the corpus callosum and increased mean diffusivity in specific brain regions, indicating potential alterations in brain connectivity related to the disorder.

Despite these microstructural changes, no significant differences in overall white matter volume were found between bulimia nervosa patients and healthy controls, suggesting that while there are subtle changes in the brain's wiring, they do not lead to observable changes in the size of white matter regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of white matter alterations along fibres in patients with bulimia nervosa: A combined voxelwise and tractography study. Chen, Q., Wang, M., Wu, GW., et al.[2023]

In a study involving 12 healthy male participants, brain activity was significantly enhanced in areas related to visual processing and decision-making during hunger, indicating that hunger alters how the brain responds to food-related images.

The research found that both hunger and satiety states influence brain activation patterns differently when exposed to food versus nonfood images, suggesting that these states have specific effects on how the brain processes visual stimuli.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain activity in hunger and satiety: an exploratory visually stimulated FMRI study. Führer, D., Zysset, S., Stumvoll, M.[2008]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Altered gray matter volume and functional connectivity in medial orbitofrontal cortex of bulimia nervosa patients: A combined VBM and FC study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Reward abnormalities among women with full and subthreshold bulimia nervosa: a functional magnetic resonance imaging study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

White matter integrity is reduced in bulimia nervosa. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

[Cognitive function in eating disorders]. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Test-retest reliability of functional MRI food receipt, anticipated receipt, and picture tasks. [2023]

6. France pubmed.ncbi.nlm.nih.gov

Characteristics of white matter alterations along fibres in patients with bulimia nervosa: A combined voxelwise and tractography study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Brain activity in hunger and satiety: an exploratory visually stimulated FMRI study. [2008]