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The Effect of Duodenal, Ileal or Combined Infusion of Tastants on Food Intake

2019年11月14日 更新者:Tim Klaassen、Maastricht University Medical Center

Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The effects of intraduodenal and/or intraileal infusion of a combination of tastants (sweet (rebaudioside A), bitter (quinine) en umami (monosodium glutamate(MSG))) and placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be investigated.

Objective: To investigate the effect of intraduodenal, intraileal and combined infusion of a combination of tastants versus infusion of placebo on food intake.

Secondary objectives:

  1. To compare the effect of intraduodenal versus intraileal versus combined intraduodenal and intraileal delivery of a combination of tastants on satiation.
  2. To assess the effect of intraduodenal and/or intraileal delivery of a combination of tastants on gastrointestinal symptoms/complaints.

研究概览

研究类型

介入性

注册 (实际的)

19

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

    • Limburg
      • Maastricht、Limburg、荷兰、6229HX
        • Maastricht University Medical Center

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

18年 至 65年 (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:

  • Based on medical history and previous examination, no gastrointestinal complaints can be defined.
  • Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
  • BMI between 18 and 25 kg/m2)
  • Weight stable over at least the last 6 months

Exclusion Criteria:

  • History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
  • Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
  • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
  • Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
  • Dieting (medically prescribed, vegetarian, diabetic, microbiological, biological dynamic)
  • Pregnancy, lactation
  • Excessive alcohol consumption (>20 alcoholic consumptions per week)
  • Smoking
  • Weight <60kg
  • Non-tasters of sweet, bitter or umami
  • Evidence of MSG-hypersensitivity or Chinese restaurant syndrome

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:预防
  • 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:Duodenal tastants, ileal placebo
Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of placebo (tap water)
Duodenal infusion of combination of tastants (sweet, bitter and umami)
Ileal infusion of placebo (tap water)
实验性的:Duodenal placebo, ileal tastants
Duodenal infusion of placebo (tap water), ileal infusion of combination of tastants (sweet, bitter and umami)
Ileal infusion of combination of tastants (sweet, bitter and umami)
Duodenal infusion of placebo (tap water)
实验性的:Duodenal tastants, ileal tastants
Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of combination of tastants (sweet, bitter and umami)
Duodenal infusion of combination of tastants (sweet, bitter and umami)
Ileal infusion of combination of tastants (sweet, bitter and umami)
安慰剂比较:Duodenal placebo, ileal placebo
Duodenal infusion of placebo (tap water), ileal infusion of placebo (tap water)
Ileal infusion of placebo (tap water)
Duodenal infusion of placebo (tap water)

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
Ad libitum meal intake
大体时间:5 weeks
Difference in ad libitum meal intake (as measured during ad libitum pasta meal) at end of the test day.
5 weeks

次要结果测量

结果测量
措施说明
大体时间
Satiation
大体时间:5 weeks
Difference in satiation (as measured by VAS) per time point.
5 weeks
GI-symptoms
大体时间:5 weeks
Difference in gastro-intestinal symptoms (as measured by VAS) per time point.
5 weeks

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。

调查人员

  • 首席研究员:Ad AM Masclee, Prof.、Maastricht University Medical Center

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)

2017年5月12日

初级完成 (实际的)

2018年5月31日

研究完成 (实际的)

2018年5月31日

研究注册日期

首次提交

2017年5月2日

首先提交符合 QC 标准的

2017年5月3日

首次发布 (实际的)

2017年5月4日

研究记录更新

最后更新发布 (实际的)

2019年11月15日

上次提交的符合 QC 标准的更新

2019年11月14日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • NL59530.068.16

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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Tastants duodenal的临床试验

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