The Effect Of Dual Treatment With L-Carnitine And Magnesium On Fatty Liver

Phase 4

• Conditions: Non Alcoholic Fatty Liver Disease

• Registration Number: NCT01956825
• Lead Sponsor: Meir Medical Center

Brief Summary

The purpose of this study is to determine whether the dual therapy of the amino acid L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease (NAFLD).

Detailed Description

The purpose of this study is to determine whether the dual therapy of the amino acid L-CARNITINE and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease.

the study is an interventional one in which 60 patients who by definition have non alcoholic fatty licer disease (NAFLD) are divided randomly (double blind) into 2 groups: group 1: "study group". receive a product (flavoured water) which contains L-CARNITINE an magnesium. group 2: control. receive placebo. regular water. Length of trial - 12 weeks. The patients will be followed on a weekly base and variuos parameters will be compared (weight, lipid profile, insulin resistance etc.).

"fibrotest" will be used at the beginning of the trial and at the end (week 12) comparing the fat content before and after the treatment.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-10-07
• Last Update Submitted: 2013-10-07
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08
• Study Start: 2014-01
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

age>18, <80 y evidence to non alcoholic fatty liver disease

Exclusion Criteria

age<18, >80 y pregnancy renal failure congestive heart failure active malignancy liver disease - etiology other than non alcoholic fatty liver disease (NAFLD). hypothyroidism/cushing total prenteral nutrition (TPN) in the last 6 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
effect of LCARNITINE and magnesium treatment on the liver fat content	12 weeks

Secondary Outcome Measures

Name	Time	Method
effect of L-CARNITINE and magnesium treatment on the metabolic panel	12 weeks	hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance

Trial Locations

Locations (1)

Meir Hospital; 🇮🇱 Kfar Saba, Israel