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

Laval University

Status: Completed

Conditions: Intestinal Permeability

Treatments: Drug: Aspirin; Dietary Supplement: Mixed meal beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT07066176

2025-178

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 3 patient groups, including a placebo group

Water

No Intervention group

Description:

Mannitol and lactulose diluted in water (500mL)

Mixed meal beverage

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Mixed meal beverage

Mixed meal beverage and aspirin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Mixed meal beverage

Drug: Aspirin