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

Mayo Clinic

Status: Enrolling

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05525845

21-010514

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Food-Print Main Arm

Other group

Description:

Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study

Treatment:

Other: Functional Magnetic Resonance Imaging (pCASL-MRI)

Other: Hedonic Meal

Other: Elemental Meal

Other: Intragastric Balloon