Carnitine and Liver Mitochondria Fatty Acid Processing

What Was Tested

The trial (not phased) is built around L-Carnitine for fatty liver & elevated liver enzymes and insulin resistance, prediabetes & type 2 diabetes.

This double-blind, placebo-controlled randomized trial will assess whether 14 days of oral carnitine supplementation modifies mitochondrial fatty acid processing in healthy young adults.

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

The registry classes the interventions as dietary supplement.

More on the Plan

Approximately 24 healthy young individuals will be enrolled, with 20 expected to complete.

The MFAP measures will be collected before and after loading participants with a high-fructose drink.

Fructose is solely metabolized by the liver.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 20 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 20-40 years. BMI of 24.5-35.5 kg/m2. Willingness to eat a prescribed diet of standard meals for a total of six days. Willingness to undergo carnitine or placebo supplementation for two weeks. Willingness to undergo study procedures including blood draws, MRS, C13 acetate infusion, DXA, muscle biopsy, and consumption of a sugary drink over the course of 6 hours.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: unstable weight in the last 3 months (gain or loss \>7 lb (3.2 kg); clinical history of diabetes or cancer; screening blood pressure \>140 systolic or \>90 diastolic.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

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 2017-05-15 with completion listed for 2018-05-11.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Liver mitochondrial fatty acid processing (time frame: Day 18).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 24 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.