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

Not Applicable

Recruiting

• Conditions: Intestinal Permeability
• Interventions: Dietary Supplement: Mixed meal beverage; Drug: Aspirin

• Registration Number: NCT07066176
• Lead Sponsor: Laval University

Brief 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.

Study Timeline

• Study First Submitted: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study Start: 2025-07-07
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Men and women
• 18-65y
• BMI <40

Exclusion Criteria

• Enteropathies
• Food intolerance or allergy related to the protocol
• Pregnancy or breastfeeding within the last 3 months
• Contraindications for aspirin - see Monograph

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mixed meal beverage	Mixed meal beverage	Mannitol and lactulose diluted in mixed meal beverage (500mL)
Mixed meal beverage and aspirin	Aspirin	Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL)
Mixed meal beverage and aspirin	Mixed meal beverage	Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL)

Primary Outcome Measures

Name	Time	Method
Intestinal permeability	From baseline to hour 5	lactulose-to-mannitol ratio in urine

Secondary Outcome Measures

Name	Time	Method
Intestinal permeability	At baseline, hour 2, hour 3 and hour 4	lactulose-to-mannitol ratio in plasma

Trial Locations

Locations (1)

INAF; 🇨🇦 Québec, Quebec, Canada