Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Serine Supplementation in Nonalcoholic Fatty Liver Disease
In this study, the investigators aim to increase the liver tissue level of GSH in NAFLD patients by short-term dietary serine supplementation and improve their liver function by lowering the oxidative stress resulting from hepatic steatosis.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - BMI 30 - 39.9 kg/m2; stable weight (+/- 2 kg) within the last six months - Sex Males, pre-, and post-menopausal females - Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives - Diagnosis NAFLD established by both liver CT and ultrasound - Consent Patients should have given their written consent to participate in this study Exclusion Criteria: - Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease) - Previous gastric or small bowel surgery - Inflammatory bowel disease - Uncontrolled diabetes mellitus (fasting blood glucose >6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease. (A subject who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH is within normal range). - Pregnancy. A urine pregnancy test will be performed the day before start of medication. Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives. - Elevations of transaminases (ALAT/ASAT) or alkaline phosphatase or bilirubin above 2xULN (upper limit of normal) the day before start of serine supplementation. - Other serious disease, including depressive disorders treated by medication - Patients who will not comply with the protocol. |
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Sweden | Hanns-Ulrich Marschall | Göteborg | |
Sweden | Sahlgrenska Academy | Göteborg |
Lead Sponsor | Collaborator |
---|---|
Hanns-Ulrich Marschall |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver fat content | Liver fat measured by magnetic resonance spectroscopy | 2 weeks | No |
Secondary | Triglycerides | 2 weeks | No | |
Secondary | Cholesterol fractions | 2 weeks | No |
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