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

Not Applicable

Completed

• Conditions: Fatty Liver, Nonalcoholic
• Interventions: Dietary Supplement: "SLIM WATER"; Other: Placebo - water

• Registration Number: NCT03319199
• Lead Sponsor: Rawi Hazzan

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.

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Study Start: 2017-10-30
• Primary Completion: 2018-01-10
• Study Completion: 2018-07-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary treatment Arm	"SLIM WATER"	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.
Placebo Arm	Placebo - water	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".

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Haemek medical center; 🇮🇱 Afula, Israel