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NCT Number: NCT05525845

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

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.

Recruiting

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Magnetic Resonance Imaging (pCASL-MRI)

Other

MRI's will be performed at multiple points on each visit day.

Intragastric Balloon

Other

Intragastric Balloon will be placed during Visit 2 study day and inflated to maximum tolerated volume. Patient will then be scanned in the MRI.

Other names: IGB

Elemental Meal

Other

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

Other

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

Primary outcomes

  1. Difference in Cerebral Blood Flow related to hypothalamus

    Time frame: 1 month

    The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area.

Secondary outcomes

  1. Cerebral Bloodflow related in multiple brain areas

    Time frame: 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.

  2. Cerebral Blood Flow between three stimuli

    Time frame: 1 month

    The mean difference in cerebral blood flow (CBF) between the 3 different stimuli.

  3. Hormone level

    Time frame: 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.

  4. comparison of calories

    Time frame: 1 month

    Correlation the caloric consumption to fullness, maximal fullness with degree of cerebral blood flow(CBF) change on PASL MRI.

  5. calorie corellation to hormones

    Time frame: 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).

  6. hormone level comparison

    Time frame: 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.

  7. Time differences in stimuli

    Time frame: 1 month

    Differences in time to next meal after maximal fullness after the three different stimulations.

  8. Caloric consumption differences in stimuli

    Time frame: 1 month

    Differences in the caloric consumption after maximal fullness after the three different stimulations.

  9. FitBit measured Physical Activity

    Time frame: 1 month

    Measurement of daily physical activity during free-living conditions measured through the use of FitBit tracker over the duration of the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Schaefer

CONTACT

[email protected]

507-266-6004

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Sep 2, 2022
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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