Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI

NCT ID: NCT05525845

Last Updated: 2025-09-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-08

Study Completion Date

2028-08-31

Brief Summary

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The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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

Group Type OTHER

Functional Magnetic Resonance Imaging (pCASL-MRI)

Intervention Type OTHER

MRI's will be performed at multiple points on each visit day.

Intragastric Balloon

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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

Intervention Type OTHER

Other Intervention Names

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IGB

Eligibility Criteria

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Inclusion Criteria

* BMI 18-25 kg/m\^2.
* 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 contraindication for MRI scanning.
* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Andres J. Acosta, M.D., Ph.D.

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Schaefer

Role: CONTACT

507-266-6004

Related Links

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Other Identifiers

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21-010514

Identifier Type: -

Identifier Source: org_study_id

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