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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2025-08-15

Brief Summary

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

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Detailed Description

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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

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Intestinal Permeability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Water

Mannitol and lactulose diluted in water (500mL)

Group Type NO_INTERVENTION

No interventions assigned to this group

Mixed meal beverage

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

Group Type PLACEBO_COMPARATOR

Mixed meal beverage

Intervention Type DIETARY_SUPPLEMENT

Mixed meal beverage

Mixed meal beverage and aspirin

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Aspirin 650mg prior mixed meal beverage

Mixed meal beverage

Intervention Type DIETARY_SUPPLEMENT

Mixed meal beverage

Interventions

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Aspirin

Aspirin 650mg prior mixed meal beverage

Intervention Type DRUG

Mixed meal beverage

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes