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临床试验/NCT02946983
NCT02946983已完成不适用

Influence of Intragastric Fructose Infusion on Behavioural and Neural Responses to Negative Emotion Induction

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 will test whether a subliminal, intragastric dose of fructose is able to influence the emotional state at the behavioural and neural level, as has been previously shown for fatty acids. They will also examine the potential involvement of gut peptide release. Based on previous research using fatty acids, an attenuating effect of fructose compared to placebo on the induced negative emotional state is hypothesized at the self-report as well as the brain level.

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
All
接受健康志愿者

入选标准

  • Healthy volunteers (N=15)
  • Male and female
  • Age 18 - 60
  • Body Mass Index (BMI) of 20 - 25 kg/m2
  • 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. Exception: IBS if the participant will be recruited in the patient group
  • Cardiovascular, respiratory, renal or urinary diseases
  • Hypertension
  • Food or drug allergies
  • Eating disorders
  • Psychotic disorders
  • Depressive disorders
  • Emotional and/or restraint eating
  • No medication on a regular basis, exception: oral contraception
  • 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)
  • 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, ...
  • 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 the endpoint of the study, with a total duration of 50 minutes

Changes in brain responses after administration of our test solution compared to baseline will be assessed via functional magnetic resonance imaging

次要结局

  • Hunger scores(every 10 minutes since the scan starts until 40 minutes after the start of the scan)
  • Mood assessment via the Self Assessment Manikin questionnaire(every 10 minutes since the scan starts until 40 minutes after the start of the scan)
  • Gut hormone levels(every 10 minutes since the scan starts until 40 minutes after the start of the scan)

研究者

申办方类型
Other
责任方
Sponsor

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