CClinicalTrials.gg
Active, not recruitingNCT05525845Updated Sep 18, 2026

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

An interventional study of Functional Magnetic Resonance Imaging (pCASL-MRI) and Intragastric Balloon in Healthy, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
21 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Other
    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

    Other: Functional Magnetic Resonance Imaging (pCASL-MRI) · Other: Intragastric Balloon · Other: Elemental Meal · Other: Hedonic Meal

Interventions

  • OtherFunctional Magnetic Resonance Imaging (pCASL-MRI)

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

  • OtherIntragastric 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.

    Also known as: IGB

  • OtherElemental Meal

    Patient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI.

  • OtherHedonic 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

06

What researchers measure

Primary outcomes

  1. Difference in Cerebral Blood Flow related to hypothalamus

    The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area.

    Time frame: 1 month

Secondary outcomes

  1. Cerebral Bloodflow related in multiple brain areas

    The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the other brain areas related to food intake regulation.

    Time frame: 1 month

  2. Cerebral Blood Flow between three stimuli

    The mean difference in cerebral blood flow (CBF) between the 3 different stimuli.

    Time frame: 1 month

  3. Hormone level

    Differences in hormones levels (ghrelin, GLP-1, CCK, PYY, leptin, insulin, GIP, amylin) at each of the stages (I.e., baseline, fullness, maximal fullness) after the three different stimulations. These hormones will be compared before and after the same stimulation days. The hormone measurements on stimulation days will also be compared to each other.

    Time frame: 1 month

  4. comparison of calories

    Correlation the caloric consumption to fullness, maximal fullness with degree of cerebral blood flow(CBF) change on PASL MRI.

    Time frame: 1 month

  5. calorie corellation to hormones

    Correlation the caloric consumption to fullness, maximal fullness with changes in the hormonal levels (ghrelin, GLP-1, CCK, PYY, leptin, insulin, GIP, amylin).

    Time frame: 1 month

  6. hormone level comparison

    Differences in the hormonal levels (ghrelin, GLP-1, CCK, PYY, leptin, insulin, GIP, amylin) between fullness and hunger after the three different stimulations. These hormones will be compared before and after the same stimulation days. The hormone measurements on stimulation days will also be compared to each other.

    Time frame: 1 month

  7. Time differences in stimuli

    Differences in time to next meal after maximal fullness after the three different stimulations.

    Time frame: 1 month

  8. Caloric consumption differences in stimuli

    Differences in the caloric consumption after maximal fullness after the three different stimulations.

    Time frame: 1 month

  9. FitBit measured Physical Activity

    Measurement of daily physical activity during free-living conditions measured through the use of FitBit tracker over the duration of the study.

    Time frame: 1 month

07

Study locations

1 site
  • Mayo Clinic Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05525845
Lead sponsor
Mayo Clinic
Responsible party
Andres J. Acosta, M.D., Ph.D. (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Sep 2, 2022
Start date
Sep 8, 2022
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 18, 2026

Study contacts

Andres Acosta, MD, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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