NL-OMON43989已完成不适用
The effect of an encapsulated nutrient mixture on ileal brake activation: A double-blind randomized study to investigate the effects on body weight, food intake and satiety - Proof of Concept study
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- •* Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. This study will include healthy adult subjects (male and female). Women must be taking contraceptives (only needed in women with childbearing potential)
- •* BMI between 25 -30 kg/m2
- •* Normal Dutch eating habits eating three meals a day including breakfast as assessed by an validated questionnaire
- •* Voluntary participation
- •* Able to participate in the study, willing to give informed consent and to comply with the study procedures and restrictions
排除标准
- •* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, 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 and documented by the principal investigator.
- •* Use of any medication, except oral contraceptives, which may interfere with this study (major interference with the execution of the experiment or potential influence on the study outcomes). This has to be decided and documented by the principle investigator.
- •* 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 90 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, diabetic and vegetarian)
- •* Pregnancy, lactation
- •* Excessive alcohol consumption (>20 alcoholic consumptions per week)
- •* Intention to stop smoking
- •* Self-admitted HIV-positive state
- •* * Above average score (>3.39 for female and >2.89 for male) on the restrained eating scale of the Dutch Eating Behaviour Questionnaire
- •* Reported unexplained weight loss or gain of >4 kg in the month prior to screening
研究者
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