Hedonic Perception and Brain Activity Response to Meal in Health and Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in activity in specific brain regions measured by functional MRI
研究概览
简要总结
The purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI.
详细描述
Functional MRI brain imaging will be performed in patients with functional dyspepsia and healthy controls in basal conditions and after a palatable test meal. During the study, the cognitive response and the hedonic dimension will be measured using 10 score scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 80 yrs
- •Body mass index between 18-30 Kg/m2
- •Right-handed
排除标准
- •Subjects with clinical history of eating-disorders
- •Subjects with clinical history of significant head-trauma
- •Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
- •Subjects with a known history of alcohol or drug abuse in the previous 6 months.
- •Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
- •Women that are pregnant or that are breast-feeding.
- •Claustrophobia
结局指标
主要结局
Change in activity in specific brain regions measured by functional MRI
时间窗: 3 hours
To determine the brain response to a meal in patients with functional dyspepsia and healthy subjects.
Cognitive and hedonic perception measured on 10 score scales (composite outcome)
时间窗: 3 hours
To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.
次要结局
- Metabolomic response measured in serum by NMR spectroscopy(3 hours)