NCT07066176

Establishing and Validating a Meal-provoked Intestinal Permeability Test for Nutritional and Metabolic Health Clinical Research.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Intestinal Permeability

Interventions

Type	Name	Description
DRUG	Aspirin	Aspirin 650mg prior mixed meal beverage
DIETARY_SUPPLEMENT	Mixed meal beverage	Mixed meal beverage

Timeline

• Start date: 2025-07-07
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2025-07-15
• Last updated: 2025-09-25

Locations

1 site across 1 country: Canada