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This is a pilot dose-finding study, which is performed with a randomized, double-blind, 3-armed, unbalanced, cross-over study design. Three of four different doses of L-lysine Monohydrate (A = 0.5 g, B = 1.2 g, C = 3.0 g and D = 7.5 g) will be applied in a randomized sequence on three different study days in six healthy volunteers. Each study day involves the repeated measurement of gastric content volume, gastric secretion volume and intestinal fluid volume using MRI before and after intragastric infusion of L-lysine Monohydrate test meals. Additionally, symptoms for hunger, fullness, nausea, bloating, abdominal cramps and urge to defecate will be recorded using a scale from 0-10. In parallel, samples of gastric juice to measure intragastric pH and pepsin concentration, samples of venous blood to assess blood pH and haematocrit as well as L-lysine, Serotonin, chloride bicarbonate and albumin plasma concentration and samples of arterialized blood from ear lobe to measure glucose blood concentration will be collected
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 0.5 | Active Comparator |
| |
| Dose 7.5 | Active Comparator |
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| Dose 3 | Active Comparator |
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| Dose 1.2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-lysine | Drug | Dose finding study for L-lysine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric half-emptying time | 120 minutes |
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Inclusion criteria: > 18, < 50 years Healthy BMI > 19, <24
Exclusion criteria: Age under 18 or above 50
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| Name | Affiliation | Role |
|---|---|---|
| Werner Schwizer, Prof. MD | University Hospital Zurich, Gastroenterology & Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Gastroenterology | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D008239 | Lysine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| D000601 | Amino Acids, Essential |