HealthyNCT05525845
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
A study testing Functional Magnetic Resonance Imaging (pCASL-MRI), Intragastric Balloon and Elemental Meal in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Functional Magnetic Resonance Imaging (pCASL-MRI), Intragastric Balloon and Elemental Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Regulation of Energy Intake - The FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans
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.
- Conditions
- Healthy
- Being tested
- Functional Magnetic Resonance Imaging (pCASL-MRI), Intragastric Balloon, Elemental Meal, Hedonic Meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance Imaging (pCASL-MRI)Other
MRI's will be performed at multiple points on each visit day.
Intragastric BalloonOther
Also called IGB
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 MealOther
Patient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI.
Hedonic MealOther
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
| Study group | Role | What they receive |
|---|---|---|
| Food-Print Main Arm | Other | Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study Receives: Other: Functional Magnetic Resonance Imaging (pCASL-MRI); Other: Intragastric Balloon; Other: Elemental Meal; Other: Hedonic Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (9)
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.
Measured: 1 month
Cerebral Blood Flow between three stimuli
The mean difference in cerebral blood flow (CBF) between the 3 different stimuli.
Measured: 1 month
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.
Measured: 1 month
comparison of calories
Correlation the caloric consumption to fullness, maximal fullness with degree of cerebral blood flow(CBF) change on PASL MRI.
Measured: 1 month
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).
Measured: 1 month
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.
Measured: 1 month
Time differences in stimuli
Differences in time to next meal after maximal fullness after the three different stimulations.
Measured: 1 month
Caloric consumption differences in stimuli
Differences in the caloric consumption after maximal fullness after the three different stimulations.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start8 Sep 2022
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres J. Acosta, M.D., Ph.D., Mayo Clinic
- Investigators
- Andres Acosta, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525845
- Sponsor's protocol ID
- 21-010514
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Regulation of Energy Intake - The FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans
- ClinicalTrials.gov ID
- NCT05525845
- Acronym / sponsor ID
- 21-010514
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food-Print Main Arm | Other | Other: Functional Magnetic Resonance Imaging (pCASL-MRI), Other: Intragastric Balloon, Other: Elemental Meal, Other: Hedonic MealFunctional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance Imaging (pCASL-MRI)MRI's will be performed at multiple points on each visit day. | Other | Food-Print Main Arm |
| Intragastric BalloonAlso: IGBIntragastric Balloon will be placed during Visit 2 study day and inflated to maximum tolerated volume. Patient will then be scanned in the MRI. | Other | Food-Print Main Arm |
| Elemental MealPatient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI. | Other | Food-Print Main Arm |
| Hedonic MealPatient 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 | Food-Print Main Arm |
Primary outcome
Difference in Cerebral Blood Flow related to hypothalamus
Time frame: 1 month
The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area.
9 secondary outcomes
Cerebral Bloodflow related in multiple brain areas
Time frame: 1 month
Cerebral Blood Flow between three stimuli
Time frame: 1 month
Hormone level
Time frame: 1 month
comparison of calories
Time frame: 1 month
calorie corellation to hormones
Time frame: 1 month
hormone level comparison
Time frame: 1 month
Time differences in stimuli
Time frame: 1 month
Caloric consumption differences in stimuli
Time frame: 1 month
FitBit measured Physical Activity
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Acosta, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Resonance Imaging (pCASL-MRI), Intragastric Balloon and Elemental Meal in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Cerebral Blood Flow related to hypothalamus (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.