The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Vitamin E 800IU per day for 12 months
Patients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week.
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study
Time frame: month 0 and month 12
Liver histology for steatosis and fibrosis staging
Time frame: month 0 and month 12
Liver immuno-histochemistry for adducts of MDA: a product of LP
Time frame: month 0 and month 12
Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation
Time frame: month 0 and month 12
Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis
Time frame: month 0 and month 12
Liver lipid peroxides and TNP-alpha
For oxidative stress and inflammation in the liver
Time frame: month 0, month 6 and month 12
Liver steatosis and volume will be assessed by ultrasound
Time frame: month 0 and month 12
Liver enzymes and IR (HOMA and QUICKY) will also be measured
Time frame: month 0, month 6 and month 12
Lipid peroxides, TNF-alpha, vitamin E and C in plasma
Parameters for oxidative stress and antioxidant capacity
Time frame: month 0, month 6 and month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.