The Effect of Duodenal, Ileal or Combined Infusion of Tastants on Food Intake
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:
- To compare the effect of intraduodenal versus intraileal versus combined intraduodenal and intraileal delivery of a combination of tastants on satiation.
- To assess the effect of intraduodenal and/or intraileal delivery of a combination of tastants on gastrointestinal symptoms/complaints.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Limburg
-
Maastricht、Limburg、荷兰、6229HX
- Maastricht University Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
调查人员
- 首席研究员:Ad AM Masclee, Prof.、Maastricht University Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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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