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

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ClinicalTrials.gov Identifier: NCT01956825
Recruitment Status : Unknown
Verified September 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):

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 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2014
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 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"


Outcome Measures

Primary Outcome Measures :
  1. effect of LCARNITINE and magnesium treatment on the liver fat content [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956825


Contacts
Contact: DAN FELDMAN, MD 0522794025 danifel100@gmail.com
Contact: YONA KITAY, MD 09-7471560 yonaki@clalit.org.il

Locations
Israel
Meir Hospital Recruiting
Kfar Saba, Israel
Contact: DAN FELDMAN, MD    0522794025    danifel100@gmail.com   
Contact: YONA KITAY, MD    09-7471560    yonaki@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: DAN FELDMAN, MD Meir Medical Center
More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01956825     History of Changes
Other Study ID Numbers: MMC13023-13CTIL
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2013

Keywords provided by Meir Medical Center:
non alcoholic fatty liver disease
LCARNITINE amino acid
magnesium
fat content

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases