Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intestinal permeability
研究概览
简要总结
Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
详细描述
Crossover clinical trial on 10 subjects (5 women, 5 men) with 3 intestinal permeability tests (3-day washout) as follows: 1) fasting; 2) meal-provoked; and 3) meal-provoked with acute aspirin challenge to assess the test's feasibility and capacity to detect alterations in intestinal permeability after aspirin-induced intestinal barrier defects.
Each test will be performed after a 12h fast. Subjects will provide fasting blood and urine samples, fully empty their bladders and drink 50mL of water with/without soluble aspirin (650mg). After 30 min., subjects will drink 500mL of water or mixed meal beverage (22g protein, 26g fat, 52g carbs) with mannitol (2g) and lactulose (4g). A standardized snack and water (200mL) will be provided at 3h. Blood samples will be taken at 2h, 3h and 4h. All urine will be collected over 5 hours. Collection times were adapted to account for potential delays in gastric emptying (mixed meal vs. water). Lactulose-to-mannitol ratios, by HPAEC-PAD method, in urine and blood will be compared by phases using mixed linear models.
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
- Single (Participant)
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
- •Men and women
排除标准
- •Enteropathies
- •Food intolerance or allergy related to the protocol
- •Pregnancy or breastfeeding within the last 3 months
- •Contraindications for aspirin - see Monograph
研究组 & 干预措施
Mixed meal beverage
Mannitol and lactulose diluted in mixed meal beverage (500mL)
干预措施: Mixed meal beverage (Dietary Supplement)
Mixed meal beverage and aspirin
Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL)
干预措施: Aspirin (Drug)
Mixed meal beverage and aspirin
Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL)
干预措施: Mixed meal beverage (Dietary Supplement)
结局指标
主要结局
Intestinal permeability
时间窗: From baseline to hour 5
lactulose-to-mannitol ratio in urine
次要结局
- Intestinal permeability(At baseline, hour 2, hour 3 and hour 4)
