NCT02511366已完成不适用
The Effect of Repetitive Ileal Brake Activation on Food Intake, Satiety, Gastrointestinal Peptide Release, Gastric Emptying and Gallbladder Volume
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ad libitum food intake
研究概览
简要总结
The appearance of intact macronutrients in the small intestine induces an intestinal brake; 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. Several studies showed that intraileal infusion of nutrients resulted in a reduction in food intake. However only acute effects were investigated in these studies and thus far it is not known whether repetitive (intermittent) infusion results in adaptation to repeated exposure and, thus, a lowered ileal brake response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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. Furthermore, we think this study would be too invasive for subjects over the age of
- •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 (≤5% weight change)
排除标准
- •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, macrobiological, biological dynamic)
- •Pregnancy, lactation
- •Excessive alcohol consumption (>20 alcoholic consumptions per week)
- •Blood donation within 3 months before the study period
- •Self-admitted HIV-positive state
- •Evidence of casein or hypersensitivity
研究组 & 干预措施
ileal infusion of casein
Experimental
Ileal infusion of casein
干预措施: Ileal infusion of casein (Other)
ileal infusion of tap water
Placebo Comparator
ileal infusion of tap water
干预措施: Ileal infusion of tap water (Other)
结局指标
主要结局
Ad libitum food intake
时间窗: 1 Day
Ad libitum food intake will be measured in kcal and the end of each test day (4 in total, all within one week)
次要结局
- Satiety(1 Day)
- Gastrointestinal peptide release (CCK)(1 Day)
- Gastrointestinal peptide release (GLP-1)(1 Day)
- Gastrointestinal peptide release (PYY)(1 Day)
- Gastrointestinal peptide release (insulin)(1 Day)
- Small intestinal transit time(1 Day)
- Gastrointestinal peptide release (glucose)(1 Day)
- gastric emptying rate(1 Day)
- Gallbladder volume(1 Day)
研究者
研究点 (1)
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