INAF
Québec, Quebec, G1Y3S8, Canada
NCT Number: NCT07066176
Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Québec, Quebec, G1Y3S8, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aspirin 650mg prior mixed meal beverage
Mixed meal beverage
Time frame: From baseline to hour 5
lactulose-to-mannitol ratio in urine
Time frame: At baseline, hour 2, hour 3 and hour 4
lactulose-to-mannitol ratio in plasma
Laval University
Other
Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
Acronym: Gut-Perm
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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