NCT07772167 · Massachusetts General Hospital
Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia
(IMAGINE)
What this study is about
This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa. The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments.
View original scientific description
This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa. The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments.
Interventions
OTHER
Functional magnetic resonance imaging (fMRI)
Pineapple pudding snack, with pre- and post-snack fMRI
Primary outcome measures
Visual interoception task
Time frame: Day 1, visit 1, 30-minute scan and visit 2 (within approximately two weeks of day 1), 30-minute scan
The study team will be investigating brain activity and connectivity during an interoception task. This will be measured via functional magnetic resonance imaging (fMRI) which is able to measure blood flow to regions of the brain.
Resting state connectivity
Time frame: Visit 2 (second visit, within approximately 2 weeks of day 1 of the study), 60 minute scan.
Change in brain activity during rest pre and post prandially using functional magnetic resonance imaging (fMRI).
Gastric peristaltic velocity
Time frame: 30 minutes (only in Visit 2, within approximately two weeks of Visit 1)
MRI-derived gastric motility outcome
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- -- Functional Dyspepsia Group:
- Males and females; ages 18-65 years
- Rome V functional dyspepsia post-prandial distress syndrome subtype
- Negative upper endoscopy or upper GI series to rule out structural/organic cause for FD
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Fluent in English
- Willing and able to provide informed consent
- Stable dose for 30 days prior to Visit 1 if on a neuropsychiatric medication (e.g., TCA, SNRI, SSRI mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)
- No current plans to initiate a new or change dosing on a neuropsychiatric medication within the study period Anorexia Nervosa Group:
- Males and females; ages 18-65 years
- DSM-5 anorexia restricting-type by the Eating Disorder Module in the Diagnostic Interview for Mood, Anxiety, and OCD and related Neuropsychiatric Disorders (DIAMOND)
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Fluent in English
- Willing and able to provide informed consent
- Stable dose for 30 days prior to Visit 1 if on an SSRI
- No current plans to initiate a new neuromodulator
- No current plans to initiate a new SSRI or change dosing on an SSRI Healthy Controls:
- Males and females; ages 18-65 years
- BMI greater than or equal to 18.5 kg/m2
- Fluent in English
- Willing and able to provide informed consent Participant
Exclusion criteria
- -- Functional Dyspepsia Group:
- Presence of other conditions that could explain the patient's symptoms by medical chart:
- Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT)
- Active H.pylori (by CLO test or stool antigen test)
- Active inflammatory bowel disease
- Eosinophilic gastroenteritis or eosinophilic esophagitis
- Acute renal failure
- Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
- Acute liver failure
- Any acute gastrointestinal process
- Any plausible structural or metabolic causes
- Heartburn as predominant symptom
- History of peptic ulcer
- Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- History of weight/shape-based eating disorder including anorexia nervosa by DIAMOND
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by modified DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent Anorexia Nervosa Group:
- Diagnosis of chronic gastrointestinal disorder
- Rome V functional dyspepsia
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by DIAMOND abbreviated suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
- Current use of neuropsychiatric medication other than an SSRI (e.g., TCA, SNRI, mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin) Healthy Controls:
- Diagnosis of chronic gastrointestinal or pain disorder
- Rome V functional dyspepsia
- greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)
- Current use of a medication known to influence gastric sensorimotor functions (including neuromodulators and SSRIs)
- Active psychiatric disorder including a feeding/eating disorder by DIAMOND
- Endorses any contraindications to MRI
- Body weight of 450 lbs or greater or BMI of 50 kg/m2 or greater (limit of MRI table)
- Allergy to pineapple (used in the test meal during MRI)
- History of GI tract surgery or any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart
- Narcotic analgesics greater than three days per week
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Current binge eating by DIAMOND
- Current self-induced vomiting by DIAMOND
- Current laxative or diuretic misuse by DIAMOND
- Current substance/alcohol use disorder within past year by DIAMOND
- Current/history of psychosis by DIAMOND
- Current mania by DIAMOND
- Active suicidal ideation by DIAMOND modified suicide module; passive suicidal ideation is allowed
- Inability or unwillingness to consume food by mouth
- Inability to provide informed consent
Where
- Boston, Massachusetts
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations