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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Difference in Cerebral Blood Flow related to hypothalamus [Срок оценки: 1 month]

Вторичные конечные точки (9)

• Cerebral Bloodflow related in multiple brain areas [Срок оценки: 1 month]
• Cerebral Blood Flow between three stimuli [Срок оценки: 1 month]
• Hormone level [Срок оценки: 1 month]
• comparison of calories [Срок оценки: 1 month]
• calorie corellation to hormones [Срок оценки: 1 month]
• hormone level comparison [Срок оценки: 1 month]
• Time differences in stimuli [Срок оценки: 1 month]
• Caloric consumption differences in stimuli [Срок оценки: 1 month]
• FitBit measured Physical Activity [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mayo Clinic Rochester — Rochester

Идентификаторы

NCT: NCT05525845 · 21-010514

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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