The Effect of L-lysine on Human Gastrointestinal Secretion: A Dose-finding Study Applying Magnetic Resonance Imaging (MRI)
- Registration Number
- NCT01579799
- Lead Sponsor
- University of Zurich
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dose 7.5 L-lysine - Dose 0.5 L-lysine - Dose 1.2 L-lysine - Dose 3 L-lysine -
- Primary Outcome Measures
Name Time Method Gastric half-emptying time 120 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Zurich, Gastroenterology
🇨ðŸ‡Zurich, ZH, Switzerland