Functional MRI Study on Food Intake Regulation in Healthy Subjects

Recruiting in Palo Alto (17 mi)

Overseen by Andres Acosta

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Appetite-altering medications

Disqualifiers: Obesity, Eating disorders, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking any medication or supplement that alters appetite, you will need to stop taking it to participate in this study.

What data supports the effectiveness of the treatment Hedonic Meal in regulating food intake?

Functional MRI studies have shown that the brain's response to food involves complex pathways related to pleasure and reward, which are influenced by hormones like ghrelin and peptide YY. These insights suggest that treatments focusing on the pleasurable aspects of eating, like a Hedonic Meal, could potentially modulate food intake by engaging these reward-related brain regions. ^{1 2 3 4 5}

Is the use of functional MRI to study food intake regulation safe for humans?

Functional MRI (fMRI) is a non-invasive imaging technique used to study brain activity and has been widely used in research to understand how the brain responds to food and appetite-related processes. It is generally considered safe for humans, as it does not involve exposure to radiation. ^{2 3 4 6 7}

How does this treatment differ from other treatments for food intake regulation?

This treatment is unique because it uses functional MRI (fMRI) to study how the brain regulates food intake by examining brain activity related to taste, aroma, and food cravings. Unlike other treatments that might focus on diet or medication, this approach provides insights into the brain's role in appetite and food-related behaviors. ^{2 3 4 8 9}

Research Team

Andres Acosta

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for healthy adults with a BMI of 18-25, stable weight for the past 3 months, and able to do light to moderate exercise. Women must be in the first half of their menstrual cycle. Exclusions include MRI contraindications, obesity history, claustrophobia, high-intensity athletes, intragastric balloon issues, food allergies or eating disorders, substance abuse including tobacco/alcohol use, psychiatric conditions or significant medical comorbidities.

Inclusion Criteria

Weight stable for 3 months prior to study entry

BMI 18-25 kg/m^2

Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures

Exclusion Criteria

Any history of psychiatric disorders

Pregnancy or nursing

Any allergies to the study meals

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo functional MRI after caloric and volumetric stimulus to study hormonal and neural responses

4 weeks

Multiple visits for MRI and hormone level assessments

Follow-up

Participants are monitored for changes in caloric consumption, hormone levels, and cerebral blood flow

4 weeks

Treatment Details

Interventions

• Hedonic Meal (Behavioural Intervention)

Trial Overview The study examines how gut hormones and brain responses differ when presented with gastric distention from an intragastric balloon versus tasteless calories versus enjoyable food using functional MRI scans to see how these factors affect hunger and appetite.

Participant Groups

Group I: Food-Print Main Arm Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Findings from Research

Functional neuroimaging techniques like PET and fMRI have begun to reveal how the human brain responds to hunger, taste, and fullness, providing insights into the neurophysiological mechanisms behind eating behaviors.

Studies show that there are distinct differences in brain function between obese and lean individuals, highlighting the complexity of obesity and suggesting that neuroimaging could be crucial for understanding and treating eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional neuroimaging: a new generation of human brain studies in obesity research. Tataranni, PA., DelParigi, A.[2019]

In a study involving 36 children aged 7-10, fMRI results showed that larger food portions activated the right inferior frontal gyrus, a brain area linked to inhibitory control, suggesting a potential reason why children may overeat when faced with larger portions.

The study also found that high energy-dense foods led to reduced activation in the left hypothalamus, but these effects were not significant after accounting for children's perceived fullness and food liking, indicating that subjective feelings may play a crucial role in food intake behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain regions implicated in inhibitory control and appetite regulation are activated in response to food portion size and energy density in children. English, LK., Fearnbach, SN., Lasschuijt, M., et al.[2018]

Neuroimaging techniques like fMRI help identify brain areas involved in food-related mental processes such as desire and satiety, which is crucial for understanding how we make decisions about eating.

By mapping these neural circuits, researchers can explore how hormonal and metabolic signals influence our psychological responses to food, potentially guiding better strategies for managing food intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging the interaction of mind and metabolism in humans. D'Agostino, AE., Small, DM.[2023]

Hedonic-motivated food intake, especially of highly rewarding foods, can disrupt the body's natural signals for hunger and fullness, leading to overeating and obesity.

Neuroimaging studies reveal that specific brain regions are involved in processing the pleasure of food, and these responses can vary based on factors like obesity, weight changes, and metabolic conditions such as type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-based etiology of weight regulation. Burger, KS., Shearrer, GE., Sanders, AJ.[2022]

This study is the first to use functional magnetic resonance imaging (fMRI) to explore the neuroanatomy of food craving, revealing that specific brain areas (hippocampus, insula, and caudate) are activated during cravings for favorite foods.

The research indicates that food cravings can be influenced by dietary manipulation, as participants reported increased cravings when on a monotonous diet, supporting the idea that food and drug cravings may share similar brain mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Images of desire: food-craving activation during fMRI. Pelchat, ML., Johnson, A., Chan, R., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Functional neuroimaging: a new generation of human brain studies in obesity research. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Imaging methodologies and applications for nutrition research: what can functional MRI offer? [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Gaining new insights into food reward with functional neuroimaging. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Brain activity in hunger and satiety: an exploratory visually stimulated FMRI study. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Cortical and limbic activation during viewing of high- versus low-calorie foods. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Brain regions implicated in inhibitory control and appetite regulation are activated in response to food portion size and energy density in children. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Neuroimaging the interaction of mind and metabolism in humans. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Brain-based etiology of weight regulation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Images of desire: food-craving activation during fMRI. [2013]