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临床试验/NCT02982616
NCT02982616已完成不适用

Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Normal Weight Subjects

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年8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
12
试验地点
2
主要终点
time evolution of gut hormones from the beginning until the end of a study visit

研究概览

简要总结

The purpose of this study is to test whether intragastrically infused fatty acid will interact with positive emotion induction and if this effect is mediated by gut hormones.

详细描述

This study aims at the possible effect of subliminal intragastric administration of fatty acids on responses to positive emotion induction, based on our earlier findings that subjective administration of fatty acid decreases neural responses to negative mood induction (Van Oudenhove et al, J Clin Invest 2011). After screening for exclusion criteria and the participants sign the informed consent form, an intravenous catheter is placed in the forearm, and a naso-gastric tube inserted through the nose. Then the test subject is connected to the equipment in order to record the activity of the autonomic nervous system, via three electrocardiogram electrodes. By using the nasogastric tube we serve a fatty acid solution (Dodecanoic acid, "fatty acid" condition) or a physiological saline solution ( "control" condition) intragastrically. The intragastric administration of low doses of this food ingredient has already been used in several previous studies by our research group and has proven perfectly safe. A positive or neutral emotional state will be induced by the combination of looking at emotional facial expressions and listening to classical music pieces that were previously validated for this purpose; This combination of incentives has already been used in previous studies of our research group. Responses will be measured by means of validated self-report scales and measurements of the vagal tone. We also take blood samples on a regular basis by the intravenous catheter for determination of gastrointestinal hormones, given our hypothesis that this may explain the effect on emotions. After removal of the nasogastric tube, the influence of subliminal administration of fatty acids and emotional state on food intake measured by means of a validated and previously drink test used in which participants "ad libitum" to drink a chocolate milkshake while the emotion-induction by means of classical music pieces continue. Finally, the intravenous catheter is removed.

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 women
  • age > 18 and <
  • Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5% of body weight in the past three months).

排除标准

  • chronic medical illness affecting the gastrointestinal, endocrine, cardiovascular or nervous system (risk of) pregnancy history of upper gastrointestinal surgery history of behavioral, therapeutic or surgical treatment aiming at or leading to weight loss/gain psychiatric disorders, including (history of) depression or eating disorders alcohol abuse or dependence regular use of medication, except for oral contraception use of any drugs, including cannabis, during the past 6 months

结局指标

主要结局

time evolution of gut hormones from the beginning until the end of a study visit

时间窗: -10min 10min 20min 30min 40min

time evolution of VAS from the beginning until the end of a study visit

时间窗: -10min 0min 10min 20min 30min 40min

visual analogue scale for appetite related sensations

次要结局

  • hedonic food intake(40min)
  • evolution of heart rate variability(-20min 20min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lukas Van Oudenhove

Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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