The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver

L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is involved in transporting fatty acids across the mitochondrial membrane, it could be an important component in treating a fatty liver disease.

The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine and Magnesium as a treatment for fatty liver.

Study Overview

• Status: Completed
• Conditions: Fatty Liver, Nonalcoholic
• Intervention / Treatment: Dietary supplement: "SLIM WATER"; Other: Placebo - water

Detailed Description

A phase 3, randomized, double blind placebo controlled study that evaluate the efficacy of L-Carnitine and Magnesium as a treatment for fatty liver, 60 eligible patients with a diagnosis of NAFDL will be randomly assigned in a 1:1 ratio to receive either the trial product " SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks, or placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". 'Follow up time is estimated to be 24 week based on monthly clinic visits and accordingly assessment of lipid profile, weight and insulin resistance.

Fibrotest will be used at the beginning of the trial and at the end (week 16) comparing the fat content before and after the treatment.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 1834111
    • Haemek medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and Female between the age 18 and 75.
• Patients with diagnosis of NAFLD when other etiologies for fatty liver were ruled out.
• Patients who sign a confirmed consent.

Exclusion Criteria:

• Patients with liver failure.
• Patients with acute or chronic renal failure ( CCT< 50 ml/min or creatinine > 1.5 mg/dl)
• Patients with congestive heart failure (NYHA 3-4)
• Patients with active cancer
• Patients on Estrogen therapy, MTX, chloroquine.
• Patients with a history of Hypothyroidism or Cushing disease.
• Patients who received TPN in the past 6 months.
• Patients with chronic liver disease, A1AT, Hemochromatosis, Wilson, Autoimmune, Toxic injury.
• Patients on anticoagulation therapy - Coumadin.
• Patients who use valproic acid therapy.
• Children, Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Primary treatment Arm; patients with a diagnosis of NAFDL will be randomly receive trial product "SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks.	Dietary supplement: "SLIM WATER"; 2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
Placebo Comparator: Placebo Arm; patients with a diagnosis of NAFDL will be randomly receive placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER".	Other: Placebo - water; for a duration of 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.	Measured with blood test in IU/L	24 weeks
Decline in serum levels of Alanine transaminase (ALT) to normal value.	Measured with blood test in IU/L	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in radiological hepatic steatosis .	Liver steatosis measured by Transient Elastography - FibrsoScan done at recruitment day and at the end of treatment.	24 weeks
Improvement in lipid profile.	Measured with blood test.	24 weeks

Collaborators and Investigators

• Sponsor: Rawi Hazzan
• Collaborators: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): July 25, 2018

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 0068-16-EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No