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

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Clalit Health Services

Status and phase

Unknown
Phase 4

Conditions

Non Alcoholic Fatty Liver Disease

Treatments

Dietary Supplement: "slim water"

Study type

Interventional

Funder types

Other

Identifiers

NCT01956825
MMC13023-13CTIL

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

water
Placebo Comparator group
Description:
just water
L-CARNITINE AND MAGNESIUM ("slim water" product)
Experimental group
Description:
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.
Treatment:
Dietary Supplement: "slim water"

Trial contacts and locations

1

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Central trial contact

DAN FELDMAN, MD; YONA KITAY, MD

Data sourced from clinicaltrials.gov

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