Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
Methionine Elimination Half-life Measured in Blood.
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.
Time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.
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.
Time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated
Time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
Hepatic Panel (Liver Laboratory Parameters)
Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)
Time frame: change from baseline at 6 weeks
Metabolic Panel (Metabolic Laboratory Parameters)
Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.
Time frame: change from baseline at 6 weeks
The Metabolic Clearance Rate Measured in the Blood.
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.
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Site Reference ID 93914
Amiens, France
Site Reference ID 93895
Angers, France
Site Reference ID 93894
Bobigny, France
Site Reference ID 93913
Montpellier, France
Site Reference ID 93916
Nice, France
Site Reference ID 93915
Paris, France
Site Reference ID 93893
Paris, France
Site Reference ID 93896
Pessac, France
Site Reference ID 93953
Bonn, Germany
Site Reference ID 93954
Frankfurt, Germany
...and 22 more locations
Time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
Methionine Volume of Distribution at Week 7 (L)
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.
Time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
Peak
Time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
Time to peak
Time frame: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
Metabolic Panel (Metabolic Laboratory Parameters)
Fasting plasma insulin
Time frame: Change from baseline at 6 weeks
Metabolic Panel (Metabolic Laboratory Parameters)
glycosylated hemoglobin (HbA1c)
Time frame: change from baseline at 6 weeks
Metabolic Panel (Metabolic Laboratory Parameters)
Adiponectin
Time frame: change from baseline at 6 weeks
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
C-reactive Protein (CRP)
Time frame: change from baseline at 6 weeks
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
glutathione in erythrocytes
Time frame: change from baseline at 6 weeks
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
oxidative stress marker (isoprostane level)
Time frame: change from baseline at 6 weeks
Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)
Caspase-cleaved cytokeratin (CK 18)
Time frame: change from baseline at 6 weeks
Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)
Hyaluronic acid
Time frame: change from baseline at 6 weeks
Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve
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.
Time frame: 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*
Hepatic Panel (Liver Laboratory Parameters)
ALT/AST ratio
Time frame: change from baseline at 6 weeks