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

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Other: Functional Magnetic Resonance Imaging (pCASL-MRI); Other: Intragastric Balloon; Other: Elemental Meal; Other: Hedonic Meal

• Registration Number: NCT05525845
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-02
• Study Start: 2022-09-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Food-Print Main Arm	Functional Magnetic Resonance Imaging (pCASL-MRI)	Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
Food-Print Main Arm	Intragastric Balloon	Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
Food-Print Main Arm	Hedonic Meal	Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
Food-Print Main Arm	Elemental Meal	Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study

Primary Outcome Measures

Name	Time	Method
Difference in Cerebral Blood Flow related to hypothalamus	1 month	The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area.

Secondary Outcome Measures

Name	Time	Method
Cerebral Bloodflow related in multiple brain areas	1 month	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.
Cerebral Blood Flow between three stimuli	1 month	The mean difference in cerebral blood flow (CBF) between the 3 different stimuli.
Time differences in stimuli	1 month	Differences in time to next meal after maximal fullness after the three different stimulations.
Caloric consumption differences in stimuli	1 month	Differences in the caloric consumption after maximal fullness after the three different stimulations.
comparison of calories	1 month	Correlation the caloric consumption to fullness, maximal fullness with degree of cerebral blood flow(CBF) change on PASL MRI.
hormone level comparison	1 month	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.
Hormone level	1 month	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.
calorie corellation to hormones	1 month	Correlation the caloric consumption to fullness, maximal fullness with changes in the hormonal levels (ghrelin, GLP-1, CCK, PYY, leptin, insulin, GIP, amylin).
FitBit measured Physical Activity	1 month	Measurement of daily physical activity during free-living conditions measured through the use of FitBit tracker over the duration of the study.

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States