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

Sponsor

Meir Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01956825

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Dietary Supplement: "slim water"	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

THE EFFECT OF DUAL TREATMENT WITH L-CARNITINE AND MAGNESIUM ON Patients With Non Alcoholic Fatty Liver Disease

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: water just water
Experimental: L-CARNITINE AND MAGNESIUM ("slim water" product) The experimental arm will receive a product "slim water", which contains 150 mg magnesium lactate and 2000 mg L-carnitine. The purpose is to follow the patients and examine several metabolic parameters over time (liver function test, lipid profile, liver fat content, etc.) and by that to show and prove the positive effect of the experimental treatment over placebo.	Dietary Supplement: "slim water"

Arm

Intervention/Treatment

Placebo Comparator: water

just water

Experimental: L-CARNITINE AND MAGNESIUM ("slim water" product)

The experimental arm will receive a product "slim water", which contains 150 mg magnesium lactate and 2000 mg L-carnitine. The purpose is to follow the patients and examine several metabolic parameters over time (liver function test, lipid profile, liver fat content, etc.) and by that to show and prove the positive effect of the experimental treatment over placebo.

Dietary Supplement: "slim water"

Outcome Measures

Primary Outcome Measures

effect of LCARNITINE and magnesium treatment on the liver fat content [12 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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