Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
NCT Number: NCT05525845
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.
Interested in participating?
Request Info21 year–50 year
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MRI's will be performed at multiple points on each visit day.
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
Patient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI.
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
Time frame: 1 month
The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area.
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.
Time frame: 1 month
The mean difference in cerebral blood flow (CBF) between the 3 different stimuli.
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.
Time frame: 1 month
Correlation the caloric consumption to fullness, maximal fullness with degree of cerebral blood flow(CBF) change on PASL MRI.
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).
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.
Time frame: 1 month
Differences in time to next meal after maximal fullness after the three different stimulations.
Time frame: 1 month
Differences in the caloric consumption after maximal fullness after the three different stimulations.
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.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
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
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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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