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Completed

NCT Number: 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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INAF

Québec, Quebec, G1Y3S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Aspirin 650mg prior mixed meal beverage

Mixed meal beverage

Dietary Supplement

Mixed meal beverage

Primary outcomes

  1. Intestinal permeability

    Time frame: From baseline to hour 5

    lactulose-to-mannitol ratio in urine

Secondary outcomes

  1. Intestinal permeability

    Time frame: At baseline, hour 2, hour 3 and hour 4

    lactulose-to-mannitol ratio in plasma

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Acronym: Gut-Perm

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Sep 25, 2025

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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