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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525845
• Other study ID #: 21-010514
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: August 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: Megan Schaefer
• Phone: 507-266-6004
• Email: RSTINDIVOBESITY[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Functional Magnetic Resonance Imaging (pCASL-MRI)
MRI's will be performed at multiple points on each visit day.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 month
Secondary	Cerebral Blood Flow between three stimuli	The mean difference in cerebral blood flow (CBF) between the 3 different stimuli.	1 month
Secondary	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.	1 month
Secondary	comparison of calories	Correlation the caloric consumption to fullness, maximal fullness with degree of cerebral blood flow(CBF) change on PASL MRI.	1 month
Secondary	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).	1 month
Secondary	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.	1 month
Secondary	Time differences in stimuli	Differences in time to next meal after maximal fullness after the three different stimulations.	1 month
Secondary	Caloric consumption differences in stimuli	Differences in the caloric consumption after maximal fullness after the three different stimulations.	1 month
Secondary	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.	1 month

External Links

•   Mayo Clinic Clinical Trials