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Development of Intestinal Permeability Tests for Clinical Nutrition and Metabolic Health Studies
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water | No Intervention | Mannitol and lactulose diluted in water (500mL) | |
| Mixed meal beverage | Placebo Comparator | Mannitol and lactulose diluted in mixed meal beverage (500mL) |
|
| Mixed meal beverage and aspirin | Experimental | Aspirin (650mg) prior to mannitol and lactulose diluted in mixed meal beverage (500mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Aspirin 650mg prior mixed meal beverage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal permeability | lactulose-to-mannitol ratio in urine | From baseline to hour 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal permeability | lactulose-to-mannitol ratio in plasma | At baseline, hour 2, hour 3 and hour 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Veilleux, PhD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INAF | Québec | Quebec | G1Y3S8 | Canada |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Mixed meal beverage |
| Dietary Supplement |
Mixed meal beverage |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |