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临床试验/NCT02946970
NCT02946970已完成不适用

Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 15 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
主要终点
Functional brain images

研究概览

简要总结

The investigators aim to study the brain mechanisms underlying the effect of subliminal (not consciously perceived) intragastric administration of bitter tastants on hunger and food intake, which was previously found. The investigators will assess brain activation patterns after an acute intragastric administration of Quinine-hydrochloride versus saline on two different test days, and will simultaneously assess a putative role of altered gut peptide release in these effects. The hypothesis is that intragastric infusion of a bitter agonist will decrease the activity in homeostatic and hedonic brain regions and that this effect is mediated by gut peptide release.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy volunteers
  • Age 18 - 60
  • Body Mass Index (BMI) of 20 - 25 kg/m
  • Stable body weight for at least 3 months prior to the start of the study

排除标准

  • Abdominal or thoracic surgery. Exception: appendectomy
  • Gastrointestinal, endocrine or neurological diseases
  • Cardiovascular, respiratory, renal or urinary diseases
  • Hypertension
  • Food or drug allergies
  • Eating disorders and people who show abnormal eating behavior
  • Depressive disorders
  • Psychotic disorders
  • No medication on a regular basis, expect for oral contraception
  • Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, ...
  • No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
  • Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
  • Pregnant or breastfeeding women
  • Claustrophobia

结局指标

主要结局

Functional brain images

时间窗: From the start of the study until 50 minutes after the start of the study

Change in brain responses after administration compared to baseline will be assessed via functional magnetic resonance imaging.

次要结局

  • Ghrelin levels(every 10 min since the scan starts until 50 minutes after the start of the scan.)
  • Motilin levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • CCK levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • PYY levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • GLP-1 levels(every 10 min since the scan starts until 50 minutes after the start of the scan)
  • hunger scores(every 10 minutes since the scan starts until until 50 minutes after the start of the scan)

研究者

申办方类型
Other
责任方
Sponsor

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