A Physiological Study on the Effect of Macronutrients Delivery to the Proximal and Distal Small Bowel on Satiety and Gut Hormone Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract
研究概览
简要总结
This study is part of a research theme aiming at elucidating the physiological mechanisms of action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure induces pronounced and sustained weight loss, but the physiological mechanisms of action are not completely clear. Neither mechanical restriction of food intake nor malabsorption, are the main contributing factors. The enhanced postprandial responses of gut hormones (e.g. GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a changed physiological set point for appetite and metabolism.
Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of the anorectic gut hormones. The higher functions of the brain will respond to these strong neuroendocrine signals by ensuing satiety and fullness.
详细描述
Ten healthy volunteers, aged 18 to 65 years will be recruited. Each subject will be studied on six occasions one week apart. On each visit, a baseline serum sample will be drawn from each subject. In a randomized way all subjects will receive the following meals in their successive weekly visits: Option 1 High protein mixed meal in capsules that break down in the stomach, Option 2 High protein mixed meal in capsules that break down in the distal small bowel, Option 3 High fat mixed meal in capsules that break down in the stomach, Option 4 High fat mixed meal in capsules that break down in the distal small bowel, Option 5 High CHD mixed meal in capsules that break down in the stomach, Option 6 High CHD mixed meal in capsules that break down in the distal small bowel. On the same day, all subjects will be offered standard ad libitum meal to measure their food consumption. After 3 hours (i.e. at 12:00) another blood sample will be drawn. All subjects will be asked to rate their appetite on a Visual Analogue Scale (VAS). Upon VAS completion the subjects will be allowed to go home.
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
- •18-65 years
- •Normal fasting glucose
- •Stable body weight for at least last three months
- •BMI < 30 Kg/m2
- •Capacity to consent to participate
- •Independently mobile
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •Pre-diabetes Diabetes
- •Substance abuse
- •Pregnancy
- •Use of medications (except for oral contraceptives)
- •Chronic medical or psychiatric illness
- •Any significant abnormalities detected on physical examination, electrocardiography, or screening blood tests (measurement of complete blood count, electrolytes, fasting glucose, and liver function)
结局指标
主要结局
The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract
时间窗: 3 hours
3 hours AUC for different gut hormones (PYY) to determine the response to macronutrients in different release (stomach vs small intestine) locations. AUC for timepoints 0, 30min, 60min, 120min, 180min.
次要结局
- Visual Analogue Scale Ratings of Hunger(180min)
- Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake(3 hours)
研究者
Carel Le Roux
Professor
Imperial College London