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临床试验/NCT07066176
NCT07066176已完成不适用

Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies

Laval University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月7日最近更新:
干预措施
相关药物

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

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

Placebo Comparator

Mannitol and lactulose diluted in mixed meal beverage (500mL)

干预措施: Mixed meal beverage (Dietary Supplement)

Mixed meal beverage and aspirin

Experimental

Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL)

干预措施: Aspirin (Drug)

Mixed meal beverage and aspirin

Experimental

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alain Veilleux

Professor

Laval University

研究点 (1)

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