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Recruiting NCT05525845

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

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional Magnetic Resonance Imaging (pCASL-MRI), Intragastric Balloon, Elemental Meal, Hedonic Meal.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 21 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Difference in Cerebral Blood Flow related to hypothalamus [Time frame: 1 month]
Secondary outcome measures (9)
  • Cerebral Bloodflow related in multiple brain areas [Time frame: 1 month]
  • Cerebral Blood Flow between three stimuli [Time frame: 1 month]
  • Hormone level [Time frame: 1 month]
  • comparison of calories [Time frame: 1 month]
  • calorie corellation to hormones [Time frame: 1 month]
  • hormone level comparison [Time frame: 1 month]
  • Time differences in stimuli [Time frame: 1 month]
  • Caloric consumption differences in stimuli [Time frame: 1 month]
  • FitBit measured Physical Activity [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic Rochester — Rochester

Identifiers

NCT: NCT05525845 · 21-010514

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗