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

Primary Purpose

Non Alcoholic Fatty Liver Disease

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

"slim water"

About this trial

This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease focused on measuring non alcoholic fatty liver disease, LCARNITINE amino acid, magnesium, fat content

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Meir Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

water

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

Arm Description

just water

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.

Outcomes

Primary Outcome Measures

effect of LCARNITINE and magnesium treatment on the liver fat content

Secondary Outcome Measures

effect of L-CARNITINE and magnesium treatment on the metabolic panel

hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance

Full Information

NCT ID

NCT01956825

First Posted

September 12, 2013

Last Updated

October 7, 2013

Sponsor

Meir Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01956825

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meir Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Alcoholic Fatty Liver Disease

Keywords

non alcoholic fatty liver disease, LCARNITINE amino acid, magnesium, fat content

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

water

Arm Type

Placebo Comparator

Arm Description

just water

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

"slim water"

Primary Outcome Measure Information:

Title

effect of LCARNITINE and magnesium treatment on the liver fat content

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

effect of L-CARNITINE and magnesium treatment on the metabolic panel

Description

hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DAN FELDMAN, MD

Phone

0522794025

danifel100@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

YONA KITAY, MD

Phone

09-7471560

yonaki@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DAN FELDMAN, MD

Organizational Affiliation

Meir Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meir Hospital

City

Kfar Saba

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DAN FELDMAN, MD

Phone

0522794025

danifel100@gmail.com

First Name & Middle Initial & Last Name & Degree

YONA KITAY, MD

Phone

09-7471560

yonaki@clalit.org.il

12. IPD Sharing Statement

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

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