Carnitine for the Treatment of Atherosclerosis.

What Was Tested

This registered phase 2 trial tested L-Carnitine.

These patients have a high risk of developing narrowing and blockages of blood vessels which occur when fat and cholesterol build up in the walls of blood vessels and form plaque.

It had two arms (groups): L-carnitine capsules (experimental) and Cellulose capsules (placebo comparator).

2x capsules twice a day - BID (4 total per day) for six months.

The registry classes the interventions as dietary supplement.

More on the Plan

Primary Question: Does L-carnitine (L-C) therapy slows down and/or regress atherosclerosis, as measured by total plaque volume (TPV) assessed by 3-dimensional (3D) carotid ultrasound in patients with metabolic syndrome?

The researchers hypothesize that L-C will regress atherosclerotic plaque formation.

Who Took Part

The registry lists 177 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Elevated BP: Systolic 130 and/or diastolic 85 mm Hg or treated.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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 and investigator.

It started in 2015-01 with completion listed for 2017-07.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in carotid Total Plaque Volume (time frame: Six months).

It also tracked 1 secondary outcome, for example Change in LDL size profile.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 177 people.

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, all human trials.