NCT02500069已完成不适用
The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release
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
- 16
- 试验地点
- 1
- 主要终点
- To measure ad libitum food intake at the end of the test day
研究概览
简要总结
The appearance of intact macronutrients in the small intestine can result in the activation of 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. The researchers will investigate the effects of intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and glucose and insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •In order to be eligible to participate in this study, a subject must meet all of the following 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 (≤5% weight change)
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •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
- •Weight <60kg
- •Evidence of casein or sucrose hypersensitivity
- •Participation in any other study in which radiation was used, within 12 months before the study period
研究组 & 干预措施
Duodenum
Experimental
Infusion of casein in duodenum
干预措施: Casein (in duodenum) (Other)
Jejunum
Experimental
Infusion of casein in jejunum
干预措施: Casein (in jejunum) (Other)
Placebo
Placebo Comparator
Tap water infusion in all three locations (duodenum, jejunum and ileum)
干预措施: placebo (Other)
Ileum
Experimental
Infusion of casein in ileum
干预措施: Casein (in ileum) (Other)
结局指标
主要结局
To measure ad libitum food intake at the end of the test day
时间窗: 1 test day
Food intake measurement in kcal
次要结局
- GI peptides(1 test day)
- VAS scores for hunger and satiety(1 test day)
研究者
研究点 (1)
Loading locations...
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