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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07066176
Acronym
Gut-Perm
Enrollment
10
Registered
2025-07-15
Start date
2025-07-07
Completion date
2025-08-15
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Permeability

Keywords

intestinal permeability

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.

Interventions

DRUGAspirin

Aspirin 650mg prior mixed meal beverage

DIETARY_SUPPLEMENTMixed meal beverage

Mixed meal beverage

Sponsors

Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intestinal permeabilityFrom baseline to hour 5lactulose-to-mannitol ratio in urine

Secondary

MeasureTime frameDescription
Intestinal permeabilityAt baseline, hour 2, hour 3 and hour 4lactulose-to-mannitol ratio in plasma

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026