The Effect Of Dual Treatment With L-Carnitine And Magnesium On Fatty Liver
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).
Non Alcoholic Fatty Liver Disease
Dietary Supplement: "slim water"
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||THE EFFECT OF DUAL TREATMENT WITH L-CARNITINE AND MAGNESIUM ON Patients With Non Alcoholic Fatty Liver Disease|
- effect of LCARNITINE and magnesium treatment on the liver fat content [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- effect of L-CARNITINE and magnesium treatment on the metabolic panel [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]hepatic enzyme profile, lipid profile, weight, inflammatory markers, insulin resistance
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: 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"|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01956825
|Contact: DAN FELDMAN, MDfirstname.lastname@example.org|
|Contact: YONA KITAY, MDemail@example.com|
|Kfar Saba, Israel|
|Contact: DAN FELDMAN, MD 0522794025 firstname.lastname@example.org|
|Contact: YONA KITAY, MD 09-7471560 email@example.com|
|Principal Investigator:||DAN FELDMAN, MD||Meir Medical Center|