Fatty Liver, Nonalcoholic
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSLIM WATER
2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
OTHERPlacebo - water
for a duration of 16 weeks
Sponsors
HaEmek Medical Center, Israel
Rawi Hazzan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female between the age 18 and 75. * Patients with diagnosis of NAFLD when other etiologies for fatty liver were ruled out. * Patients who sign a confirmed consent.
Exclusion criteria
* Patients with liver failure. * Patients with acute or chronic renal failure ( CCT\< 50 ml/min or creatinine \> 1.5 mg/dl) * Patients with congestive heart failure (NYHA 3-4) * Patients with active cancer * Patients on Estrogen therapy, MTX, chloroquine. * Patients with a history of Hypothyroidism or Cushing disease. * Patients who received TPN in the past 6 months. * Patients with chronic liver disease, A1AT, Hemochromatosis, Wilson, Autoimmune, Toxic injury. * Patients on anticoagulation therapy - Coumadin. * Patients who use valproic acid therapy. * Children, Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value. | 24 weeks | Measured with blood test in IU/L |
| Decline in serum levels of Alanine transaminase (ALT) to normal value. | 24 weeks | Measured with blood test in IU/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in radiological hepatic steatosis . | 24 weeks | Liver steatosis measured by Transient Elastography - FibrsoScan done at recruitment day and at the end of treatment. |
| Improvement in lipid profile. | 24 weeks | Measured with blood test. |
Countries
Israel
Outcome results
None listed