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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Difference in Cerebral Blood Flow related to hypothalamus
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18-25 kg/m^
- •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.
排除标准
- •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.
研究组 & 干预措施
Food-Print Main Arm
Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
干预措施: Functional Magnetic Resonance Imaging (pCASL-MRI) (Other)
Food-Print Main Arm
Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
干预措施: Intragastric Balloon (Other)
Food-Print Main Arm
Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
干预措施: Elemental Meal (Other)
Food-Print Main Arm
Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study
干预措施: Hedonic Meal (Other)
结局指标
主要结局
Difference in Cerebral Blood Flow related to hypothalamus
时间窗: 1 month
The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area.
次要结局
- Cerebral Bloodflow related in multiple brain areas(1 month)
- Cerebral Blood Flow between three stimuli(1 month)
- Time differences in stimuli(1 month)
- Caloric consumption differences in stimuli(1 month)
- comparison of calories(1 month)
- hormone level comparison(1 month)
- Hormone level(1 month)
- calorie corellation to hormones(1 month)
- FitBit measured Physical Activity(1 month)
研究者
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic