| Outcome Measures: |
- Methionine Elimination Half-life Measured in Blood.; time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*; After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.- Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.; time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*; After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.<br>- 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test; time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*; parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated<br>- Hepatic Panel (Liver Laboratory Parameters); time frame: change from baseline at 6 weeks; Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)<br>- Metabolic Panel (Metabolic Laboratory Parameters); time frame: change from baseline at 6 weeks; Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.<br>- The Metabolic Clearance Rate Measured in the Blood.; time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*; After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.<br>- Methionine Volume of Distribution at Week 7 (L); time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*; After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.<br>- 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test; time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*; Peak<br>- 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test; time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*; Time to peak<br>- Metabolic Panel (Metabolic Laboratory Parameters); time frame: Change from baseline at 6 weeks; Fasting plasma insulin<br>- Metabolic Panel (Metabolic Laboratory Parameters); time frame: change from baseline at 6 weeks; glycosylated hemoglobin (HbA1c)<br>- Metabolic Panel (Metabolic Laboratory Parameters); time frame: change from baseline at 6 weeks; Adiponectin<br>- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters); time frame: change from baseline at 6 weeks; C-reactive Protein (CRP)<br>- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters); time frame: change from baseline at 6 weeks; glutathione in erythrocytes<br>- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters); time frame: change from baseline at 6 weeks; oxidative stress marker (isoprostane level)<br>- Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers); time frame: change from baseline at 6 weeks; Caspase-cleaved cytokeratin (CK 18)<br>- Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers); time frame: change from baseline at 6 weeks; Hyaluronic acid<br>- Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve; time frame: 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*; After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.<br>- Hepatic Panel (Liver Laboratory Parameters); time frame: change from baseline at 6 weeks; ALT/AST ratio
|
