NCT03319199

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Rawi Hazzan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Fatty Liver, Nonalcoholic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	"SLIM WATER"	2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
OTHER	Placebo - water	for a duration of 16 weeks

Timeline

• Start date: 2017-10-30
• Primary completion: 2018-01-10
• Completion: 2018-07-25
• First posted: 2017-10-24
• Last updated: 2019-08-09

Locations

1 site across 1 country: Israel