Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
NCT ID: NCT05525845
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2022-09-08
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Food-Print Main Arm
Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
Functional Magnetic Resonance Imaging (pCASL-MRI)
MRI's will be performed at multiple points on each visit day.
Intragastric Balloon
Intragastric Balloon will be placed during Visit 2 study day and inflated to maximum tolerated volume. Patient will then be scanned in the MRI.
Elemental Meal
Patient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI.
Hedonic Meal
Patient will ingest meal of their choice from a local food delivery service and eat until they reach their maximum level of fullness. Once full, the patient will be scanned in the MRI
Interventions
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Functional Magnetic Resonance Imaging (pCASL-MRI)
MRI's will be performed at multiple points on each visit day.
Intragastric Balloon
Intragastric Balloon will be placed during Visit 2 study day and inflated to maximum tolerated volume. Patient will then be scanned in the MRI.
Elemental Meal
Patient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI.
Hedonic Meal
Patient will ingest meal of their choice from a local food delivery service and eat until they reach their maximum level of fullness. Once full, the patient will be scanned in the MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight stable for 3 months prior to study entry.
* For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
* Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures..
* Ability to perform light to moderate physical activity.
Exclusion Criteria
* Any history of childhood (\> 95th percentile) or adult obesity (BMI \>30 kg/m\^2).
* Claustrophobia.
* High intensity training or physical activity.
* Any contraindication for intragastric balloon insertion.
* Any allergies to the study meals.
* Any history of eating disorder.
* Any substance abuse disorder (including alcohol and tobacco).
* Any history of psychiatric disorders.
* Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
* Pregnancy or nursing.
* Any history of bariatric surgery or endoscopic bariatric procedure.
* Use of any medication or supplement that alters appetite.
* Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.
21 Years
50 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Andres Acosta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-010514
Identifier Type: -
Identifier Source: org_study_id
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