Trial Outcomes & Findings for Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group (NCT NCT01754714)
NCT ID: NCT01754714
Last Updated: 2016-02-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
Results posted on
2016-02-19
Participant Flow
Participant milestones
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
No study drug was administered
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
26
|
28
|
|
Overall Study
COMPLETED
|
27
|
26
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group
Baseline characteristics by cohort
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=27 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=26 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=28 Participants
no study drug was administered
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
51.9 years
STANDARD_DEVIATION 13.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
49 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Methionine Elimination Half-life Measured in Blood.
|
4.29 hour
Standard Deviation 1.86
|
4.66 hour
Standard Deviation 1.57
|
4.25 hour
Standard Deviation 1.64
|
4.26 hour
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.
|
4.02 mcg/mL
Standard Deviation 0.92
|
3.81 mcg/mL
Standard Deviation 0.67
|
5.68 mcg/mL
Standard Deviation 10.13
|
5.62 mcg/mL
Standard Deviation 8.53
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
13C methionine breath test recovery at 30 min (%)
|
0.93 percentage of recovery
Standard Deviation 0.73
|
0.77 percentage of recovery
Standard Deviation 0.51
|
0.88 percentage of recovery
Standard Deviation 0.66
|
0.69 percentage of recovery
Standard Deviation 0.55
|
|
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
13C methionine breath test recovery at 60 min (%)
|
3.66 percentage of recovery
Standard Deviation 1.99
|
3.49 percentage of recovery
Standard Deviation 1.74
|
3.61 percentage of recovery
Standard Deviation 1.78
|
2.98 percentage of recovery
Standard Deviation 1.72
|
|
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
13C methionine breath test recovery at 90 min (%)
|
6.69 percentage of recovery
Standard Deviation 2.75
|
6.60 percentage of recovery
Standard Deviation 2.56
|
6.68 percentage of recovery
Standard Deviation 2.48
|
5.74 percentage of recovery
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksSerum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Hepatic Panel (Liver Laboratory Parameters)
ALP
|
1.9 U/L
Standard Deviation 7.9
|
-0.1 U/L
Standard Deviation 13.7
|
3.4 U/L
Standard Deviation 24.1
|
-6.0 U/L
Standard Deviation 16.9
|
|
Hepatic Panel (Liver Laboratory Parameters)
ALT
|
-6.2 U/L
Standard Deviation 19.5
|
-6.3 U/L
Standard Deviation 23.5
|
-4.9 U/L
Standard Deviation 32.2
|
-11.9 U/L
Standard Deviation 33.4
|
|
Hepatic Panel (Liver Laboratory Parameters)
AST
|
-5.1 U/L
Standard Deviation 15.7
|
-3.0 U/L
Standard Deviation 16.5
|
-1.2 U/L
Standard Deviation 10.7
|
-11.6 U/L
Standard Deviation 27.7
|
|
Hepatic Panel (Liver Laboratory Parameters)
GGT
|
-1.1 U/L
Standard Deviation 33.7
|
-10.6 U/L
Standard Deviation 62.7
|
-2.7 U/L
Standard Deviation 35.7
|
-12.3 U/L
Standard Deviation 48.1
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksFasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Metabolic Panel (Metabolic Laboratory Parameters)
Cholesterol
|
-0.131 mmol/L
Standard Deviation 0.593
|
0.046 mmol/L
Standard Deviation 0.921
|
-0.265 mmol/L
Standard Deviation 0.601
|
-0.134 mmol/L
Standard Deviation 0.659
|
|
Metabolic Panel (Metabolic Laboratory Parameters)
HDL
|
-0.094 mmol/L
Standard Deviation 0.166
|
-0.046 mmol/L
Standard Deviation 0.254
|
-0.098 mmol/L
Standard Deviation 0.169
|
-0.075 mmol/L
Standard Deviation 0.188
|
|
Metabolic Panel (Metabolic Laboratory Parameters)
LDL
|
0.125 mmol/L
Standard Deviation 0.452
|
0.182 mmol/L
Standard Deviation 0.762
|
-0.202 mmol/L
Standard Deviation 0.589
|
-0.112 mmol/L
Standard Deviation 0.558
|
|
Metabolic Panel (Metabolic Laboratory Parameters)
HOMA-R
|
0.837 mmol/L
Standard Deviation 13.232
|
0.127 mmol/L
Standard Deviation 3.763
|
-1.549 mmol/L
Standard Deviation 13.321
|
3.432 mmol/L
Standard Deviation 10.837
|
|
Metabolic Panel (Metabolic Laboratory Parameters)
Glucose
|
-0.068 mmol/L
Standard Deviation 0.968
|
0.490 mmol/L
Standard Deviation 1.486
|
-0.163 mmol/L
Standard Deviation 1.009
|
-0.121 mmol/L
Standard Deviation 1.610
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
The Metabolic Clearance Rate Measured in the Blood.
|
8.86 L/h
Standard Deviation 2.93
|
9.83 L/h
Standard Deviation 3.27
|
10.05 L/h
Standard Deviation 4.32
|
8.23 L/h
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Methionine Volume of Distribution at Week 7 (L)
|
54.40 L
Standard Deviation 18.43
|
62.84 L
Standard Deviation 14.04
|
64.58 L
Standard Deviation 17.77
|
8.23 L
Standard Deviation 53.98
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*Peak
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
|
1.0972 Atom %C13
Standard Deviation 0.0062
|
1.0964 Atom %C13
Standard Deviation 0.0052
|
1.0964 Atom %C13
Standard Deviation 0.0053
|
1.0949 Atom %C13
Standard Deviation 0.0045
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*Time to peak
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test
|
70.0 minutes
Interval 50.0 to 80.0
|
70.0 minutes
Interval 60.0 to 90.0
|
70.0 minutes
Interval 50.0 to 80.0
|
70.0 minutes
Interval 60.0 to 90.0
|
SECONDARY outcome
Timeframe: Change from baseline at 6 weeksFasting plasma insulin
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Metabolic Panel (Metabolic Laboratory Parameters)
|
0.3 pmol/L
Standard Deviation 191.0
|
-13.6 pmol/L
Standard Deviation 115.5
|
-13.1 pmol/L
Standard Deviation 248
|
69.1 pmol/L
Standard Deviation 309.0
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksglycosylated hemoglobin (HbA1c)
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Metabolic Panel (Metabolic Laboratory Parameters)
|
-0.08 Percentage
Standard Deviation 0.28
|
-0.06 Percentage
Standard Deviation 0.36
|
-0.05 Percentage
Standard Deviation 0.32
|
0.02 Percentage
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksAdiponectin
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Metabolic Panel (Metabolic Laboratory Parameters)
|
0.754 mcg/mL
Standard Deviation 4.191
|
0.425 mcg/mL
Standard Deviation 1.199
|
0.219 mcg/mL
Standard Deviation 1.661
|
0.045 mcg/mL
Standard Deviation 1.515
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksC-reactive Protein (CRP)
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
|
-0.79 nmol/L
Standard Deviation 15.51
|
-0.80 nmol/L
Standard Deviation 14.90
|
-8.02 nmol/L
Standard Deviation 20.40
|
-4.80 nmol/L
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksglutathione in erythrocytes
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
|
-0.24 mcmol/g
Standard Deviation 2.06
|
-0.21 mcmol/g
Standard Deviation 1.01
|
0.05 mcmol/g
Standard Deviation 1.41
|
-0.30 mcmol/g
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksoxidative stress marker (isoprostane level)
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
|
-0.223 ng/mg Crea
Standard Deviation 0.801
|
0.116 ng/mg Crea
Standard Deviation 0.699
|
0.290 ng/mg Crea
Standard Deviation 0.691
|
-0.223 ng/mg Crea
Standard Deviation 0.641
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksCaspase-cleaved cytokeratin (CK 18)
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)
|
-126.8 U/L
Standard Deviation 401.1
|
-136.6 U/L
Standard Deviation 257.3
|
-47.0 U/L
Standard Deviation 157.3
|
-143.2 U/L
Standard Deviation 532.5
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksHyaluronic acid
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)
|
4.67 ng/mL
Standard Deviation 48.52
|
2.03 ng/mL
Standard Deviation 32.26
|
9.40 ng/mL
Standard Deviation 59.63
|
3.02 ng/mL
Standard Deviation 46.56
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve
|
440.09 mcg/mL
Standard Deviation 149.96
|
399.30 mcg/mL
Standard Deviation 148.90
|
425.24 mcg/mL
Standard Deviation 231.88
|
460.57 mcg/mL
Standard Deviation 135.63
|
SECONDARY outcome
Timeframe: change from baseline at 6 weeksALT/AST ratio
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Hepatic Panel (Liver Laboratory Parameters)
|
-0.02 Ratio
Standard Deviation 0.23
|
0.01 Ratio
Standard Deviation 0.21
|
0.03 Ratio
Standard Deviation 0.18
|
-0.01 Ratio
Standard Deviation 0.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline at 6 weeksCytokine profile ( Interleukin-6, IL-8, IL-10 (IL), Tumor Necrosis Factor (TNF -α), monocyte chemoattractant protein (MCP-1), and Granulocyte-colony stimulating factor (G-CSF ).
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
IL-6: n= (27,24,23,27)
|
0.0603 pg/mL
Standard Deviation 2.0263
|
-0.9254 pg/mL
Standard Deviation 6.4599
|
-1.3194 pg/mL
Standard Deviation 4.5779
|
0.1597 pg/mL
Standard Deviation 1.6243
|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
IL-8: n= (8,6,7,9)
|
-14.41 pg/mL
Standard Deviation 41.07
|
0.65 pg/mL
Standard Deviation 13.37
|
-78.73 pg/mL
Standard Deviation 187.51
|
-6.17 pg/mL
Standard Deviation 16.94
|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
IL-10: n= (1,2,1,2)
|
0.270 pg/mL
Standard Deviation NA
not calculated as there was data of only 1 patient available
|
-0.045 pg/mL
Standard Deviation 0.106
|
-0.300 pg/mL
Standard Deviation NA
not calculated as there was data of only 1 patient available
|
1.600 pg/mL
Standard Deviation 1.146
|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
TNF-alpha: n= (24,24,20,27)
|
-0.127 pg/mL
Standard Deviation 0.414
|
-1.083 pg/mL
Standard Deviation 4.782
|
-0.601 pg/mL
Standard Deviation 2.136
|
-0.187 pg/mL
Standard Deviation 1.114
|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
MCP-1: n= (27,25,24,27)
|
-29.75 pg/mL
Standard Deviation 154.75
|
-20.60 pg/mL
Standard Deviation 79.71
|
-40.15 pg/mL
Standard Deviation 96.21
|
-44.51 pg/mL
Standard Deviation 114.85
|
|
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)
G-CSF: n= (5,4,1,0)
|
-20.0 pg/mL
Standard Deviation 52.8
|
-0.5 pg/mL
Standard Deviation 9.7
|
20.0 pg/mL
Standard Deviation NA
not calculated as there was data of only 1 patient available
|
NA pg/mL
Standard Deviation NA
not calculated as there was no data of patients available
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline at 6 weeksNon-invasive test for liver disease (ActiTest)/Fibrotest FibroTest® : diagnoses hepatic fibrosis ActiTest® : assesses viral necro-inflammatory activity Scores between 0 and 1, the higher the score the worse The FibroTest score is calculated from the results of a six-parameter blood test, combining six serum markers with the age and gender of the patient:Alpha-2-macroglobulin, Haptoglobin, Apolipoprotein A1, Gamma-glutamyl transpeptidase (GGT), Total bilirubin, and Alanine transaminase (ALT). ALT is used in a second assessment called ActiTest that is part of FibroTest.
Outcome measures
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 Participants
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=26 Participants
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 Participants
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=27 Participants
No study drug was administered
|
|---|---|---|---|---|
|
Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)
ActiTest Score
|
-0.017 scores on a scale
Standard Deviation 0.098
|
-0.022 scores on a scale
Standard Deviation 0.137
|
-0.002 scores on a scale
Standard Deviation 0.168
|
-0.042 scores on a scale
Standard Deviation 0.096
|
|
Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)
Fibrotest Score
|
0.036 scores on a scale
Standard Deviation 0.097
|
0.028 scores on a scale
Standard Deviation 0.093
|
0.050 scores on a scale
Standard Deviation 0.125
|
0.020 scores on a scale
Standard Deviation 0.068
|
Adverse Events
1000 mg SAMe (S-adenosyl-L-methionine)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
1500 mg SAMe
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
2000 mg SAMe
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
No Treatment
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 participants at risk
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=27 participants at risk
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 participants at risk
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=28 participants at risk
No study drug was administered
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
head injury and neck injury before start of treatment
|
0.00%
0/27
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28 • Number of events 1
|
Other adverse events
| Measure |
1000 mg SAMe (S-adenosyl-L-methionine)
n=27 participants at risk
SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
1500 mg SAMe
n=27 participants at risk
SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
2000 mg SAMe
n=24 participants at risk
SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
No Treatment
n=28 participants at risk
No study drug was administered
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
11.1%
3/27 • Number of events 3
|
7.4%
2/27 • Number of events 2
|
16.7%
4/24 • Number of events 4
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/27
|
3.7%
1/27 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/28
|
|
General disorders
Fatigue
|
7.4%
2/27 • Number of events 2
|
0.00%
0/27
|
0.00%
0/24
|
0.00%
0/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place