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The Effects of Intragastric Administration of Nutrients on Executive Control in Healthy Subjects.

2017年9月7日 更新者:Universitaire Ziekenhuizen KU Leuven

The previous research by one of our members in the research team (H. Miller) suggests a possible influence of oral nutrients intake of certain fat or carbohydrates (glucose, fructose) on executive control. On the other hand, another previous study from our group (L. Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids on subjective and neural responses to negative emotion induction. The purpose of this study therefore is to examine the effect of intragastric administration of certain fatty acids and carbohydrates on executive control in healthy volunteers.

Therefore one group of healthy volunteers are invited to the study. The participants will be randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube in each of the visits. After the exposure period, participants will use a computer to perform there different tasks to measure executive control. During each study visit, regular measurements of emotion, physical sensations, as well as blood glucose will be assessed. Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal function.

研究概览

研究类型

介入性

注册 (实际的)

26

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Leuven、比利时、3000
        • University Hospitals Leuven, Campus Gasthuisberg

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

17年 及以上 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • N = 26 These numbers are based on a power calculation for a repeated measures ANOVA with one within-subject factor using Gpower software version 3.1.7 (http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3), indicating that these sample sizes are needed to achieve 90% power to detect a medium-sized effect (f = 0.25).
  • Men & women
  • Age: >17 years
  • 20 ≤ BMI ≤ 25
  • Of good mental and physical health

Exclusion Criteria:

Participants with one or more of self-reported points below will be excluded:

  1. History of, or current presence of:

    • Psychiatric disorders (e.g., anxiety disorders, somatization disorder, eating disorders, depression, substance-related disorders alcohol abuse or dependence etc.)
    • Abnormal eating behavior (including restraint and emotional eating)
    • Abdominal/thoracic surgery
    • Neurological, endocrine or digestive related disorders
    • Head trauma with loss of consciousness
    • Other serious medical conditions
    • Use of any drugs, including cannabis, during the past 6 months
  2. Current presence of:

    • Pregnancy
    • Medication use that affects the function of the gastrointestinal tract and/or affects the nervous system, psychotropics or painkillers
    • A recent accident or surgery that has not fully recovered
  3. Other

    • Smoking
    • Women not taking hormonal contraception

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Lauric acid
the nutrient that can be widely found in daily food.
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
实验性的:Palmitic acid
the nutrient that can be widely found in daily food.
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
实验性的:Capric acid
the nutrient that can be widely found in daily food.
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
安慰剂比较:Saline
physiological salt water
Intragastric infusion of nutrient that can be widely found in daily food or placebo.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
trial making task
大体时间:60 min after intervention
Participants will be required to connect a set of 25 numbered dots in numerical order as fast as possible while still maintaining accuracy.
60 min after intervention
digital span task
大体时间:60 min after intervention
Participants will be presented with a series of single-digit numbers and required to remember them. After the series has been presented the participants will need to indicate the numbers presented.
60 min after intervention
memory task
大体时间:60 min after intervention
A list of 15 words that are matched for frequency, concreteness, and imagery will be presented to the participant via a computer monitor at the rate of one every 2 sec. Afterwards they will be given 60 sec to write down as many words as they are able to recall from the list. Accuracy and errors will be recorded.
60 min after intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年5月25日

初级完成 (实际的)

2017年6月27日

研究完成 (实际的)

2017年6月27日

研究注册日期

首次提交

2016年6月6日

首先提交符合 QC 标准的

2016年6月9日

首次发布 (估计)

2016年6月15日

研究记录更新

最后更新发布 (实际的)

2017年9月11日

上次提交的符合 QC 标准的更新

2017年9月7日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • S56123

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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