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

NCT ID: NCT01956825

Last Updated: 2013-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Non Alcoholic Fatty Liver Disease

Keywords

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non alcoholic fatty liver disease LCARNITINE amino acid magnesium fat content

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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water

just water

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

"slim water"

Intervention Type DIETARY_SUPPLEMENT

Interventions

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"slim water"

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DAN FELDMAN, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir Hospital

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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DAN FELDMAN, MD

Role: CONTACT

Phone: 0522794025

Email: [email protected]

YONA KITAY, MD

Role: CONTACT

Phone: 09-7471560

Email: [email protected]

Facility Contacts

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DAN FELDMAN, MD

Role: primary

YONA KITAY, MD

Role: backup

Other Identifiers

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MMC13023-13CTIL

Identifier Type: -

Identifier Source: org_study_id