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

October 7, 2013 updated by: Meir Medical Center

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
effect of LCARNITINE and magnesium treatment on the liver fat content
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of L-CARNITINE and magnesium treatment on the metabolic panel
Time Frame: 12 weeks
hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: DAN FELDMAN, MD, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2014

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC13023-13CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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