Effects of Carnitine Supplementation on Liver and Muscle

What Was Tested

In this not phased trial, researchers set out to test L-Carnitine for fatty liver & elevated liver enzymes and insulin resistance, prediabetes & type 2 diabetes.

Participants will be given either Carnitine or placebo, together with a meal replacement milkshake twice daily for 6 months.

It had two arms (groups): Carnitine and Meal Replacement Drink (experimental) and Placebo and Meal Replacement Drink (placebo comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

NAFLD occurs when too much fat accumulates in liver tissue.

This can, over time, cause inflammation and scarring of the liver, eventually leading to chronic liver disease and cirrhosis.

Muscle and liver are the major sites in the body which coordinate glucose and fat metabolism.

As well as assessing the effect of carnitine supplementation on liver fat, its effect on metabolic processes within these tissues will also be measured.

Who Took Part

30 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Elevated liver fat on screening abdominal ultrasound. Capable of providing informed consent. BMI \<40 kg/m2. Negative non-invasive liver screen, including Hepatitis B and C serology, liver autoantibodies, transferrin saturation, α1-antitrypsin levels.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: known history of cardiovascular disease; known diabetes mellitus; known psychiatric comorbidity.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-04-02 with completion listed for 2020-08-30.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Intrahepatic triglyceride (IHTG) content (time frame: 24 weeks).

It also tracked 6 secondary outcomes, for example liver sensitivity to insulin, whole body insulin sensitivity, Muscle lipid content, Skeletal muscle sensitivity to insulin, whole body composition and Liver energy metabolism.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 30 people with fatty liver & elevated liver enzymes.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Fatty liver & elevated liver enzymes research, Insulin resistance, prediabetes & type 2 diabetes research.