Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
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
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Sep 2022
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedStudy Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
September 18, 2025
September 1, 2025
5.9 years
August 16, 2022
September 13, 2025
Conditions
Outcome Measures
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.
1 month
Secondary Outcomes (9)
Cerebral Bloodflow related in multiple brain areas
1 month
Cerebral Blood Flow between three stimuli
1 month
Hormone level
1 month
comparison of calories
1 month
calorie corellation to hormones
1 month
- +4 more secondary outcomes
Study Arms (1)
Food-Print Main Arm
OTHERFunctional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
Interventions
MRI's will be performed at multiple points on each visit day.
Intragastric Balloon will be placed during Visit 2 study day and inflated to maximum tolerated volume. Patient will then be scanned in the MRI.
Patient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Andres Acosta, MD, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 16, 2022
First Posted
September 2, 2022
Study Start
September 8, 2022
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share