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Can a pudding snack reveal how the brain misreads the stomach?

NCT ID NCT07772167

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study explores how the brain and stomach communicate in people with functional dyspepsia (a condition causing stomach pain and fullness without a clear cause) and anorexia nervosa. Participants will eat a pineapple pudding snack while undergoing brain scans (fMRI) before and after eating, allowing researchers to measure brain activity and stomach motility. The goal is to identify patterns in gut-brain signaling that could improve understanding of these conditions and guide future treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pineapple pudding snack with pre- and post-snack fMRI
What this could lead to
If successful, this could improve understanding of gut-brain communication, potentially pointing toward better treatments for functional dyspepsia and anorexia nervosa.
What could go wrong
This is an observational brain-imaging study, not a treatment trial, so it won't directly test a therapy. Results may not lead to immediate clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Participant 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 * Illiteracy * 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 * Illiteracy * 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 * Illiteracy * 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

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Conditions

The condition(s) this trial relates to.

anorexia nervosa dyspepsia functional gastric disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anorexia nervosa Functional dyspepsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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