The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver

Conditions
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Fatty Liver, Nonalcoholic

Intervention / Treatment
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* Dietary Supplement: SLIM WATER
* Other: Placebo - water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Primary treatment Arm<br>patients with a diagnosis of NAFDL will be randomly receive trial product SLIM WATER that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks. | Dietary Supplement: SLIM WATER<br>* 2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks<br>|
| Placebo Comparator: Placebo Arm<br>patients with a diagnosis of NAFDL will be randomly receive placebo for the initial 8 weeks and continue another 8 weeks with the trial product SLIM WATER. | Other: Placebo - water<br>* for a duration of 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value. | Measured with blood test in IU/L | 24 weeks | 
| Decline in serum levels of Alanine transaminase (ALT) to normal value. | Measured with blood test in IU/L | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in radiological hepatic steatosis . | Liver steatosis measured by Transient Elastography - FibrsoScan done at recruitment day and at the end of treatment. | 24 weeks | 
| Improvement in lipid profile. | Measured with blood test. | 24 weeks |