L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is involved in transporting fatty acids across the mitochondrial membrane, it could be an important component in treating a fatty liver disease. The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine and Magnesium as a treatment for fatty liver.
A phase 3, randomized, double blind placebo controlled study that evaluate the efficacy of L-Carnitine and Magnesium as a treatment for fatty liver, 60 eligible patients with a diagnosis of NAFDL will be randomly assigned in a 1:1 ratio to receive either the trial product " SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks, or placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". 'Follow up time is estimated to be 24 week based on monthly clinic visits and accordingly assessment of lipid profile, weight and insulin resistance. Fibrotest will be used at the beginning of the trial and at the end (week 16) comparing the fat content before and after the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
22
2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
for a duration of 16 weeks
Haemek medical center
Afula, Israel
The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.
Measured with blood test in IU/L
Time frame: 24 weeks
Decline in serum levels of Alanine transaminase (ALT) to normal value.
Measured with blood test in IU/L
Time frame: 24 weeks
Improvement in radiological hepatic steatosis .
Liver steatosis measured by Transient Elastography - FibrsoScan done at recruitment day and at the end of treatment.
Time frame: 24 weeks
Improvement in lipid profile.
Measured with blood test.
Time frame: 24 weeks
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