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

Rawi Hazzan

Status: Completed

Conditions: Fatty Liver, Nonalcoholic

Treatments: Dietary Supplement: "SLIM WATER"; Other: Placebo - water

Study type: Interventional

Funder types: Other

Identifiers

NCT03319199

0068-16-EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Primary treatment Arm

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: "SLIM WATER"

Placebo Arm

Placebo Comparator group

Description:

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".

Treatment:

Other: Placebo - water