The Effect of L-lysine on Human Gastrointestinal Secretion: A Dose-finding Study Applying Magnetic Resonance Imaging (MRI)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: L-lysine

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria: > 18, < 50 years Healthy BMI > 19, <24

Exclusion criteria: Age under 18 or above 50

• Pathologic underweight or overweight (BMI <19 or >24 (kg/m2))
• Previous gastrointestinal, cardio-respiratory (incl. arterial hypertension), hematologic (anaemia), renal, hepatic, atopic, alimentary disease, psychiatric disease, epilepsy, panic attacks, diabetes drug or alcohol abuse, lysinuria, galactosaemia
• Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Incretin-mimetics, non-steroidal anti-inflammatory drugs, Macrolidantibiotica
• Subjects unable to stop medication within 48 prior the study begins that alters serotonin blood profiles , including paracetamol, cumarine, mephenesin, phenobarbital, acetanilide, ephedrine, amphetamine, phentolamin, phenacetin, methocarbamol, acetylsalicylic acid, levodopa, promethazine, isoniazid, methenamine, streptozocin, chlorpromazine
• Positive helicobacter pylori test
• Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
• Presence of metallic implants, devices or metallic foreign bodies
• Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
• Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
• Mental capacity (DSM IV, inter alia Claustrophobia), which limits the capability to fulfill the demands of the study
• Known allergy or intolerance against capsaicin, locus bean gum, L-lysine, DOTAREM®, Fructose, Gluten, Galactose Known allergic reaction after prior injection of lidocaine (e.g. at the dentist )
• Known allergic reaction toward methylparaben (E218)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dose 0.5	Drug: L-lysine; Dose finding study for L-lysine
ACTIVE_COMPARATOR: Dose 7.5	Drug: L-lysine; Dose finding study for L-lysine
ACTIVE_COMPARATOR: Dose 3	Drug: L-lysine; Dose finding study for L-lysine
ACTIVE_COMPARATOR: Dose 1.2	Drug: L-lysine; Dose finding study for L-lysine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastric half-emptying time	120 minutes

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (ESTIMATE): April 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: KEK-ZH-NR. 2012-0005